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as described by: Kevin T. Foley, M.D. Department of Neurosurgery University of Tennessee Memphis, Tennessee CD HORIZON ® SEXTANT Rod Insertion System Surgical Technique MINIMAL ACCESS SPINAL T ECHNOLOGIES SM

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Page 1: CD HORIZON SEXTANT Rod Insertion System Surgical Technique · Rod Insertion Instrumentation works well regardless of the grafting technique chosen. I hope you find the CD HORIZON

as described by:Kevin T. Foley, M.D.Department ofNeurosurgeryUniversity of TennesseeMemphis, Tennessee

CD HORIZON® SEXTANT™

Rod Insertion System Surgical Technique

MINIMAL ACCESS SPINAL TECHNOLOGIESSM

Page 2: CD HORIZON SEXTANT Rod Insertion System Surgical Technique · Rod Insertion Instrumentation works well regardless of the grafting technique chosen. I hope you find the CD HORIZON

Dear Colleagues:

Although it can be highly effective, lumbar pedicle fixation has some well-known drawbacks.

One of these, which has been termed “fusion disease,” is a result of the significant spinal

exposure and paraspinous muscle stripping necessary to place traditional spinal hardware.

The CD HORIZON SEXTANT Rod Insertion System was designed to minimize the

approach-related morbidity of traditional lumbar pedicle fixation. The instrumentation uses

CD HORIZON® M8 Multi Axial Screw implants and pre-contoured rods that are inserted

percutaneously. This is made possible by the use of a geometrically constrained inserter that

passes the rod directly into the screw heads through a small stab wound.

Bone grafting techniques will vary depending on the indication. I will typically place the bone

graft anteriorly through laparoscopic portals. If decompression is required, I will perform a

minimally invasive posterior interbody technique through METRx™ System tubes. When faced

with revision surgery, I may choose a minimally invasive posterolateral graft. The SEXTANT

Rod Insertion Instrumentation works well regardless of the grafting technique chosen.

I hope you find the CD HORIZON SEXTANT Rod Insertion System an effective tool in your

practice. I have personally found that my patients benefit from the reduced morbidity in

both short and long terms. For the right indications, this fixation method has become my

technique of choice.

Sincerely,

Kevin T. Foley, M.D.

1

PREFACEROD INSERTION SYSTEMROD INSERTION SYSTEM

MMIINNIIMMAALL AACCCCEESSSS SSPPIINNAALL TTEECCHHNNOOLLOOGGIIEESS

CD HORIZON®

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Instruments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3

Instruments and Implants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

Preliminary Steps

Preoperative Planning and Set Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5

Positioning of Skin Incisions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

Considering Pedicle Anatomy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7

Considering Navigation Options–FluoroNav™ Virtual Fluoroscopy System . . . . . . .8

Surgical Technique Steps

Accessing the Pedicle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9

Dilate the Fascia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12

Pedicle Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13

Screw Extender Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14

Screw Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17

Second Screw Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18

Connect the Extenders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19

Attach the Rod Inserter and Rod Trocar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .20

Passing the Trocar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .21

Rod Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .22

Passing the Rod . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .23

Final Tightening . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .24

Assembly Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .25

Closure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26

Product Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .27

Important Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .28

2

ROD INSERTION SYSTEMROD INSERTION SYSTEM CONTENTS

MMIINNIIMMAALL AACCCCEESSSS SSPPIINNAALL TTEECCHHNNOOLLOOGGIIEESS

CD HORIZON®

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INSTRUMENTS

3

Rod Inserter Assembly (8675300)

Screw Extender B

Screw Extender A

Rod Inserter

Lock Screw Retaining Sleeve

ROD INSERTION SYSTEMROD INSERTION SYSTEM

Quick Connect Ratcheting T-Handle (836-009)

Rod Template (8670096)

Quick Connect Modular Handle (836-010)

Quick Connect Ratcheting Handle (836-011)

Taps(4.5, 5.5, 6.5mm, and Self-Drilling)

Large Dilator (8675422)

5.3mm METRx™ System Dilator (9560420)

9.4mm METRx™ System Dilator (9560421)

CD HORIZON®

Rod Trocar Tip (8670030)

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Compressor Handle (8670095)Final Plug Driver Shaft (8670090)

Extender Reattachment Driver (8670021)

Combination Plug Driver (8670040)

M8 Multi Axial Screwdriver (8670020)

Quick Connect Pedicle Probe (8670003)

ROD INSERTION SYSTEMROD INSERTION SYSTEMINSTRUMENTS AND IMPLANTS

IMPLANTS

4

Quick Connect Trocar (8670000)

Trocar/Probe Sleeve (8670007)

Disposable Guidewire, Sharp (8670002) Disposable Guidewire, Blunt (8670001)

5.5mm Pre-Bent Titanium Rod (Available in lengths from 30 to 90mm)

Cannulated M8 Multi Axial Set Screw (8670855)

Cannulated M8 Multi Axial Screw (Available in 5.5, 6.5, and 7.5mm diameter with lengths from 35 to 55mm.)

CD HORIZON®

ONE-TIME USE INSTRUMENTS

PAK NeedleAvailable with one Bevel and one Trocar tip (8670009); with two Beveled Tips (8670010); or with two Trocar Tips (8670015)

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P R E L I M I N A R Y

PREOPERATIVE PLANNING AND SET UPSTEP 1

“I prefer to use chest rolls instead of a frame,as they are completely radiolucent.”

– Kevin Foley, M.D.

Figure 1

Figure 2

ROD INSERTION SYSTEM5

Preoperative planning can be useful in determining the proper starting point andscrew trajectory. An axial view demonstrates the distance lateral to the pedicle ini-tially taken through the skin (Figure 1). The starting point is rarely directly overthe pedicle.

When using the CD HORIZON SEXTANT Rod Insertion System the patientshould be positioned prone, lying flat on the table. Either a radiolucent frame orchest rolls may be used, but a knee to chest position should be avoided. Verifythat adequate fluoroscopic images of the pedicles can be obtained in both an APand lateral view before proceeding (Figure 2). Some tables have pedestals thatmake it difficult to get a true AP view of the pedicles, especially at the S1 level.While adjustments in patient positioning can be made, tables that limit good APfluoro should generally be avoided. A longer prep area is also necessary becausethe rod inserter can have an entry point relatively far away from the levels beinginstrumented.

ROD INSERTION SYSTEM

CD HORIZON®

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ROD INSERTION SYSTEM

Figure 4A Figure 4B

P R E L I M I N A R Y

POSITIONING OF SKIN INCISIONS

A 22-gauge spinal needle can be used to verify the appropriate location of theskin incisions. The needle is positioned on the skin directly over the pedicle onan AP image. The needle is then moved laterally 1 to 2cm and inserted throughthe skin to the intersection of the facet and transverse process (Figure 3). BothAP and lateral images confirm that the appropriate starting place has beendetermined (Figures 4A and 4B).

Figure 3

STEP 2

6

CD HORIZON®

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P R E L I M I N A R Y

CONSIDERING PEDICLE ANATOMY

Consider the pedicle as roughly a cylindrical structure. The ideal starting point is at the intersection of the facet and the transverse process (the lateral edge ofthe cylinder). As the pedicle is navigated, the trajectory should be aimed towardthe medial wall, but not approach it too closely (Figure 5).

STEP 3

“I prefer placing the heads of the screws lateral to thefacet for a number of reasons. This position helps avoidthe superior facet, aids in lowering the profile, and helpsfollow the natural inclination of the pedicles.”

– Kevin Foley, M.D.

7

Figure 5

ROD INSERTION SYSTEMROD INSERTION SYSTEM

CD HORIZON®

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P R E L I M I N A R Y

CONSIDERING NAVIGATION OPTIONS–FLUORONAV™ VIRTUAL FLUOROSCOPY SYSTEM

STEP 4

The FluoroNav System can also provide assistance with pedicle navigation. The SEXTANT instrumentation is designed to work interchangeably with theFluoroNav System making integration a very simple proposition. An additionalmodule containing all of the necessary attachments is required for utilizing theFluoroNav System (Figure 6).

The primary benefit of using the FluoroNav System is that a green virtual extension of the instruments will demonstrate the safety of any proposed pedicle trajectory (Figure 7). The proper trajectory can be determined prior tonavigating the pedicle. Another important benefit relates to the ability to seemultiple views simultaneously without the increase of radiation exposure.

Figure 7

“The red line represents the position of the probe at theentry to the pedicle. The green line is a virtual extensionalong the probe’s trajectory. The trajectory can beadjusted until it is ideal prior to navigating the pedicle.”

– Kevin Foley, M.D.

8ROD INSERTION SYSTEM

Figure 6

ROD INSERTION SYSTEM

CD HORIZON®

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ROD INSERTION SYSTEM

Needle InsertionA PAK Needle is used to gain access to the pedicle. After placing the PAK Needle at the intersection of the facet and the transverse process, the needle may beadvanced partially through the pedicle (Figure 8). An AP image should show theneedle tip at the lateral margin of the pedicle initially (Figures 9A and 9B). As theneedle advances towards the base of the pedicle, on the lateral image, it shouldapproach the pedicle center on the AP image (Figures 9C and 9D).

ROD INSERTION SYSTEM

S U R G I C A L T E C H N I Q U E

ACCESSING THE PEDICLE (NEEDLE OPTION)STEP 5

Figure 9A Figure 9B Figure 9C Figure 9D

Figure 8

9

“I generally place both needles before moving onto the next step. I find that my visualization ofthe second pedicle is accomplished more easilywhen done before the initial screw is inserted.”

– Kevin Foley, M.D.

CD HORIZON®

See page 11 for alternate pedicle access option.

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Guidewire InsertionThe inner stylet of the needle is removed to allow the guidewire to be inserted intothe pedicle (Figures 10 and 11). Be extremely careful with regards to the position of the guidewire . Unintentional advancement of the wire can potentiallybe very dangerous. Once the guidewire is inserted, the needle may be removed.

Figure 11

Figure 10

10

“The guidewire is not meant to be used as a dissectingtool. Rather, it serves as a ‘switching stick’ so that youare able to easily re-find the pedicle.”

– Kevin Foley, M.D.

S U R G I C A L T E C H N I Q U E

ACCESSING THE PEDICLE (NEEDLE OPTION CONT.)STEP 5

ROD INSERTION SYSTEM

CD HORIZON®

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Figure 13

Figure 12

S U R G I C A L T E C H N I Q U E

ACCESSING THE PEDICLE (AWL/PROBE OPTION)

ROD INSERTION SYSTEM

STEP 5

CD HORIZON®

Awl InsertionThe Quick Connect Trocar (Awl) may also be used to gain access to the pedicle.First insert the Trocar through the Trocar/Probe Sleeve. After placing the Trocar atthe intersection of the facet and the transverse process, the Trocar/Probe Sleevemay be docked onto the pedicle and the Trocar advanced partially through thepedicle. Remove the Trocar while maintaining the Trocar/Probe Sleeve in place(Figure 12). If further dissection is desired, the Quick Connect Pedicle Probe maybe inserted into the pedicle through the Trocar/Probe Sleeve and advanced. Afterremoving the Probe, insert the Guidewire Centering Sleeve into the Trocar/ProbeSleeve (Figure 13). Insert the Guidewire into the pedicle through the sleeves, then remove both sleeves.

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S U R G I C A L T E C H N I Q U E

DILATE THE FASCIA

The fascia and muscle must be dilated to allow for screw placement. Three dilators are used to gently make a path of the appropriate dimension (Figures 14 and 15). The first two dilators are removed, leaving the third dilator to serve as a tissue protection sleeve during the tapping step.

Figure 15

Figure 14

12ROD INSERTION SYSTEM

STEP 6

CD HORIZON®

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S U R G I C A L T E C H N I Q U E

PEDICLE PREPARATION

13

STEP 4

Figure 16

Figure 17

The pedicle is prepared by placing the tap over the guidewire and through thethird dilation sleeve (Figure 16). In dense bone, where the screw may be difficultto advance, ensure that the pedicle is fully prepared by using a tap the samesize as the inserted screw to avoid possible screwdriver damage. Fluoroscopyshould be used to verify the position of the guidewire and the tap during thisstep (Figure 17). Screw length can be determined by using the calibrationmarkings on the shaft of the tap. After tapping, remove the dilator but leave theguidewire in place.

ROD INSERTION SYSTEM

STEP 7

CD HORIZON®

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S U R G I C A L T E C H N I Q U E

SCREW EXTENDER ASSEMBLY

14

Before a screw can be inserted into the pedicle, the screw extenders must beassembled to the Multi Axial Screws. First, a set screw is placed in the set screw retaining sleeve by pushing the smooth cap of the set screw into the distal end of the sleeve (Figure 18). Make certain the threads are not inside thesleeve (Figure 19).

Next, the sleeve is placed into the screw extender (Figure 20). Initially the twobuttons on the extender must be depressed, but they should be released afterthe sleeve is partially inserted. As the sleeve slides down, an audible “click” willbe heard, confirming the sleeve is in the correct, most upward position (Figure 21). NOTE: The proper position of the sleeve is very important as it willallow for the rod to engage the saddle of the Multi Axial Screw.

Figure 20

Figure 18

Figure 21

Figure 19

ROD INSERTION SYSTEM

STEP 8

CD HORIZON®

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S U R G I C A L T E C H N I Q U E

SCREW EXTENDER ASSEMBLY (CONT.)

15

STEP 8

Figure 22

Figure 23

A CD HORIZON® Cannulated M8 Multi Axial Screw is placed in the distal end ofthe extender (Figure 22) and the combination plug driver is used to advance theset screw (Figure 23). The inner sleeve prevents the set screw from traveling toofar into the saddle of the M8 screw. Before implantation, check to make sure theset screw is in the appropriate position by visual inspection and by manually passing a rod between the screw head and the set screw.

ROD INSERTION SYSTEM

CD HORIZON®

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S U R G I C A L T E C H N I Q U E

SCREW EXTENDER ASSEMBLY (CONT.)

16

The screwdriver is placed into the screw assembly from the top. The tip of thescrewdriver passes through the set screw and into the head of the Multi Axial Screw(Figure 24). Since the screwdriver passes through the set screw, care should betaken during screwdriver insertion and removal. This will ensure the position of theset screw is not changed by the screwdriver (Figure 25).

Figure 25

Figure 24

ROD INSERTION SYSTEM

STEP 8

CD HORIZON®

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S U R G I C A L T E C H N I Q U E

SCREW PLACEMENT

The entire screw extender assembly is inserted over the guidewire and into thepedicle. If the screw is difficult to advance, remove the assembly while leaving theguidewire in place, and ensure the pedicle is fully prepared by using a tap thesame size as the inserted screw. This will avoid possible screwdriver damage.After driving the screw assembly into the pedicle, remove the guidewire to preventit from being advanced. Be certain that the screw assembly is not inserted too far.If the multi axial head of the M8 screw is driven too forcefully against bone, it willlose its multi axial capabilities making it difficult to connect the assemblies duringsubsequent steps (Figures 26 and 27).

17

Figure 27

Figure 26

ROD INSERTION SYSTEM

STEP 9

CD HORIZON®

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The process is repeated for the second screw on the same side (Figure 28). Afterinserting both, the screw assemblies should be at approximately the same heightoutside of the patient. Both assemblies should move freely following insertion.

S U R G I C A L T E C H N I Q U E

SECOND SCREW PLACEMENT

18

Figure 28

“Pay close attention to where the heads of thescrews end up. Their position determines rod trajectory in both a sagittal and coronal plane.Also keep in mind that changing the position ofthe heads, by either ‘wanding’ the extenders oraltering screw height, will help avoid things likefacets, and the iliac crest.”

– Kevin Foley, M.D.

ROD INSERTION SYSTEM

STEP 10

CD HORIZON®

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Rotate the extenders so the two flat sides are facing each other (Figure 29). Themale and female parts are then mated together and rotated so there is no gapbetween the two extenders. Once the extenders are connected and the flat surfaces are completely flush, the rod inserter can be attached.

“Pay particular attention to how the extenders line up. Look betweenthem and make sure the flat sides are perfectly matched. If they are not,twist the two extenders until they are. Extenders that are not connectedcorrectly will cause the rod to miss one or more of the screw heads.”

– Kevin Foley, M.D.

19

S U R G I C A L T E C H N I Q U E

CONNECT THE EXTENDERS

Figure 29

ROD INSERTION SYSTEM

STEP 11

CD HORIZON®

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S U R G I C A L T E C H N I Q U E

ATTACH THE ROD INSERTER AND ROD TROCAR

The rod inserter is attached to the two screw assemblies by lining up the pegs ofthe inserter and the grooves of the assemblies (Figure 30). The thumb screw onthe side of the inserter is tightened to attach the device securely. A rod trocar tipmust then be placed into the tip of the rod inserter by backing out, and thenpushing down the thumb screw on top of the inserter (Figure 31). After the trocar is in place, tighten the thumb screw to securely fasten the tip.

20ROD INSERTION SYSTEM

STEP 12

CD HORIZON®

Figure 31

Figure 30

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S U R G I C A L T E C H N I Q U E

PASSING THE TROCAR

The rod trocar is used to help make a path through the fascia and muscle downto the saddle of the first screw (Figure 32). A small skin incision is required,then the trocar is advanced through the muscle until it hits the first screw saddle as confirmed on lateral fluoroscopy.

21

Figure 32

ROD INSERTION SYSTEM

STEP 13

CD HORIZON®

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22

S U R G I C A L T E C H N I Q U E

ROD MEASUREMENT

The appropriate rod length may be determined by placing the rod templates intothe two screw extenders (Figure 33). If the template is beyond the line of a particular rod length, the next size rod must be used. After determining rod size,the templates are removed before rod insertion. In the figure below, 60mm isthe appropriate size rod.

Figure 33

ROD INSERTION SYSTEM

STEP 14

CD HORIZON®

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“You should never apply excessive force (such as a mallet)to the inserter when passing the rod. If the rod does noteasily pass through both screws, reassess the situation.”

– Kevin Foley, M.D.

S U R G I C A L T E C H N I Q U E

PASSING THE ROD

Figure 34

Replace the rod trocar with the appropriate sized rod as determined by the rodtemplate. Trocar removal is accomplished by reversing the steps for attachment.Pass the rod through the screw heads so the tapered tip of the rod is completelythrough the distal screw as verified by lateral fluoroscopy (Figures 34 and 35).

23ROD INSERTION SYSTEM

STEP 15

Figure 35

CD HORIZON®

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Figure 36

S U R G I C A L T E C H N I Q U E

FINAL TIGHTENING

After verifying with AP, lateral, and oblique views that the rod is seated in the headsof both screws, the set screws can be tightened. NOTE: Before attempting to tightenthe set screws, the lock screw retaining sleeves must be lowered! Press the buttons onthe screw extenders and push the inner sleeves down. This step allows the setscrews to engage the rod.

The compressor handles may be used for provisional tightening (Figure 36). Withboth handles in place, the construct can be compressed, held and provisionallytightened. Final tightening is achieved with the final plug driver by tightening untilthe set screw heads shear off (Figure 37). The sheared-off portion of the set screwswill be retained inside the retaining sleeves.

24

Figure 37

“The set screws should firmly tightenafter 1 1/4 rotations. If they do not,then the rod is not seated properly with the screw saddle.”

– Kevin Foley, M.D.

ROD INSERTION SYSTEM

STEP 16

CD HORIZON®

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S U R G I C A L T E C H N I Q U E

ASSEMBLY REMOVAL

The rod inserter must be detached from the rod by again reversing the steps ofattachment. After the inserter is disconnected from the rod, the entire rod inserterassembly may now be pulled out of the patient (Figure 38). The final constructcan then be viewed with AP and lateral fluoroscopy (Figures 39A and 39B).

Figure 38

Figure 39A

Figure 39B

25 ROD INSERTION SYSTEM

STEP 17

CD HORIZON®

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STEP 18 S U R G I C A L T E C H N I Q U E

CLOSURE

The entire process is repeated for the contra-lateral side. Closure is accomplished with a fewinterrupted stitches in the fascia, a subcuticular skin suture, and Steri Strips™ (Figure 40).

Figure 40

26

Post-Op Lateral View Post-Op AP View

ROD INSERTION SYSTEM

CD HORIZON®

NOTE: Implant ExplantationThe CD HORIZON® M8 Cannulated Multi Axial Screw set screws and rods may be removedby applying the combination plug driver from the SEXTANT instrumentation set to the setscrew and turning counter-clockwise until the set screw is removed. The M8 CannulatedMulti Axial Pedicle Screws may be removed by applying the M8 Multi Axial screwdriver orextender reattachment driver from the SEXTANT instrumentation set to the screw and turn-ing counter-clockwise until the screw is removed from the pedicle.

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27

ROD INSERTION SYSTEMROD INSERTION SYSTEMPRODUCT INFORMATION

CANNULATED M8 MULTI AXIAL TITANIUM SCREWS AND SET SCREWSITEM # DESCRIPTION QUANTITY ITEM # DESCRIPTION QUANTITY8675535 5.5mm x 35mm 4 8676550 6.5mm x 50mm 6

8675540 5.5mm x 40mm 4 8676555 6.5mm x 55mm 4

8675545 5.5mm x 45mm 4 8677530 7.5mm x 30mm 4

8675550 5.5mm x 50mm 4 8677535 7.5mm x 35mm 4

8676535 6.5mm x 35mm 4 8677540 7.5mm x 40mm 4

8676540 6.5mm x 40mm 6 8677545 7.5mm x 45mm 4

8676545 6.5mm x 45mm 6 8670855 Set Screws 12

PRE-BENT TITANIUM RODSITEM # DESCRIPTION QUANTITY ITEM # DESCRIPTION QUANTITY

8672030 5.5mm X 30mm 3 8672055 5.5mm x 55mm 3

8672035 5.5mm x 35mm 3 8672060 5.5mm x 60mm 3

8672040 5.5mm x 40mm 3 8672070 5.5mm x 70mm 3

8672045 5.5mm x 45mm 3 8672080 5.5mm x 80mm 3

8672050 5.5mm x 50mm 3 8672090 5.5mm x 90mm 3

ONE-TIME USE INSTRUMENTSITEM # DESCRIPTION QUANTITY ITEM # DESCRIPTION QUANTITY

8670001 Guidewire, Blunt 4 8670009 PAK Needle, 1 Beveled and 1 Trocar Tip

8670002 Guidewire, Sharp 4 8670010 PAK Needle, 2 Beveled Tips

8670015 PAK Needle, 2 Trocar Tips

(PAK Needle Sold Seperately)

INSTRUMENTSITEM # DESCRIPTION QUANTITY ITEM # DESCRIPTION QUANTITY

836-009 Quick Connect Ratcheting T-Handle 1 8670045 4.5mm Tap 1

836-010 Quick Connect Modular Handle 1 8670055 5.5mm Tap 1

836-011 Quick Connect Ratcheting Handle 1 8670065 6.5mm Tap 1

8670000 Quick Connect Trocar 1 8670085 Self-Drilling Tap 1

8670003 Quick Connect Pedicle Probe 1 8670090 Final Plug Driver Shaft 1

8670004 Guidewire Centering Sleeve 1 8670095 Compressor Handle 2

8670007 Trocar/Probe Sleeve 1 8670096 Rod Template 2

8670020 M8 Multi Axial Screwdriver 2 8675300 Rod Inserter Assembly 1

8670021 Reattachment Driver 1 8675422 Large Dilator 1

8670030 Rod Trocar Tip 2 9560420 5.3mm METRX™ System Dilator 1

8670040 Combination Plug Driver 1 9560421 9.4mm METRX™ System Dilator 1

CASES AND TRAYSITEM # DESCRIPTION QUANTITY ITEM # DESCRIPTION QUANTITY

8671001 Instrument Base 1 8671002 Lower Instrument Tray 1

8671003 Upper Instrument Tray 1 8671005 Implant Lid 1

185-064 Base Lid 1 8671004 Instrument Tray 1

CD HORIZON®

Page 29: CD HORIZON SEXTANT Rod Insertion System Surgical Technique · Rod Insertion Instrumentation works well regardless of the grafting technique chosen. I hope you find the CD HORIZON

28

PURPOSE:

The CD HORIZON® Spinal System is intended to help provide immobilization and stabilization of spinal segmentsas an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.

DESCRIPTION:The CD HORIZON® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, CROSSLINK®

Plates, staples and connecting components, as well as implant components from other MEDTRONIC SOFAMORDANEK spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tai-lor-made for the individual case.

Certain implant components from other MEDTRONIC SOFAMOR DANEK spinal systems can be used with the CDHORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates,connectors, staples and washers, GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors; LIBER-TY® rods and screws; DYNALOK PLUS™ bolts. Please note that certain components are specifically designed toconnect to ø4.5mm, ø5.5mm, or ø6.35mm rods, while other components can connect to both ø5.5mm rods andø6.35mm rods. Care should be taken so that the correct components are used in the spinal construct.

CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE™

rods and associated screws are intended for anterior use only. However, for patients of smaller stature,CD HORIZON® 4.5mm rods and associated components may be used posteriorly.

The CD HORIZON® Spinal System implant components are fabricated from medical grade stainless steel describedby such standards as ASTM F138 or ISO 5832-1 or ISO 5832-9. Alternatively, the entire system may be made outof medical grade titanium or titanium alloy described by such standards as ASTM F67 or ASTM F136 or ISO 5832-3 or 5832-2. MEDTRONIC SOFAMOR DANEK expressly warrants that these devices are fabricated from one of theforegoing material specifications. No other warranties, express or implied, are made. Implied warranties of mer-chantability and fitness for a particular purpose or use are specifically excluded. See the MSD Catalog for furtherinformation about warranties and limitations of liability. Never use stainless steel and titanium implant compo-nents in the same construct.

The CD HORIZON® Spinal System also includes anterior staples made of Shape Memory Alloy (Nitinol – NiTi).Shape Memory Alloy is compatible with titanium implants only. Do not use with stainless steel.

To achieve best results, do not use any of the CD HORIZON® Spinal System implant components with componentsfrom any other system or manufacturer unless specifically allowed to do so in this or another MEDTRONICSOFAMOR DANEK document. As with all orthopaedic and neurosurgical implants, none of the CD HORIZON®

Spinal System components should ever be reused under any circumstances.

INDICATIONS, CONTRAINDICATIONS AND POSSIBLE ADVERSE EVENTS:

INDICATIONS:The CD HORIZON® System is intended for the following indications:

When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, theCD HORIZON® Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis withobjective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinaltumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the CD HORIZON® Spinal System is indicated for skele-tally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1)vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixedor attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after thedevelopment of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the CD HORIZON® Spinal System isintended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic originwith degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3)spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthro-sis, (7) tumor resection, and/or (8) failed previous fusion.

When used in a percutaneous posterior approach with the SEXTANT™ instrumentation, the CD HORIZON®

Cannulated M8 Multi-Axial Screw components are intended for the following indications:

When used as a pedicle screw fixation system the CD HORIZON® Cannulated M8 Multi-Axial Screw componentsare also indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifthlumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) whoare having the device fixed or attached to the lumbar and sacral spine (L3 and below); (d) who are having thedevice removed after the development of a solid fusion mass.

In addition, when used as a posterior spine thoracic/lumbar system, the CD HORIZON® Cannulated M8 Multi-AxialScrew components are intended for: (1) degenerative disc disease (as defined by back pain of discogenic originwith degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3)spondylolisthesis, (4) spinal deformities (i.e. degenerative scoliosis, kyphosis, and/or lordosis), (5) fracture, (6)pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The CD HORIZON® ECLIPSE™ components are intended for the following indications:

When used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System is intended for the fol-lowing indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degenerationof the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4)spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection,and/or (8) failed previous fusion.

In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected tothe VERTEX® Reconstruction System with the VERTEX® rod connector. When connecting to the VERTEX®

Reconstruction System in the cervical spine, components are intended for the following indications:

When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the VERTEX®

Reconstruction System is indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

HOOKS AND RODSThe hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dis-location or trauma in the cervical/upper thoracic (C1-T3) spine.

SCREWS/LATERAL CONNECTORSThe use of screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) is limited to placement in T1-T3 in treat-ing thoracic conditions only. The screws are not intended to be placed in the cervical spine.

Titanium ATLAS™ Cable System to be used with the VERTEX® Reconstruction System allows for cable attachmentto the posterior cervical or thoracic spine.

CONTRAINDICATIONS:

Contraindications include, but are not limited to:1. Active infectious process or significant risk of infection (immunocompromise).2. Signs of local inflammation.3. Fever or leukocytosis. 4. Morbid obesity.5. Pregnancy.6. Mental illness.7. Grossly distorted anatomy caused by congenital abnormalities.8. Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery,

such as the presence of congenital abnormalities, elevation of sedimentation rate unexplained by other dis-eases, elevation of white blood count (WBC), or a marked left shift in the WBC differential count.

9. Rapid joint disease, bone absorption, osteopenia, osteomalacia and/or osteoporosis. Osteoporosis orosteopenia is a relative contraindication since this condition may limit the degree of obtainable correction,stabilization, and/or the amount of mechanical fixation.

10. Suspected or documented metal allergy or intolerance.11. Any case not needing a bone graft and fusion.12. Any case where the implant components selected for use would be too large or too small to achieve a suc-

cessful result. 13. Any case that requires the mixing of metals from two different components or systems.14. Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality.15. Any patient in which implant utilization would interfere with anatomical structures or expected physiological

performance.16. Any patient unwilling to follow postoperative instructions.17. Any case not described in the indications.POTENTIAL ADVERSE EVENTSAll of the possible adverse events associated with spinal fusion surgery without instrumentation are possible. Withinstrumentation, a listing of potential adverse events includes, but is not limited to:

1. Early or late loosening of any or all of the components.2. Disassembly, bending, and/or breakage of any or all of the components.3. Foreign body (allergic) reaction to implants, debris, corrosion products (from crevice, fretting, and/or gen-

eral corrosion), including metallosis, staining, tumor formation, and/or autoimmune disease.4. Pressure on the skin from component parts in patients with inadequate tissue coverage over the implant

possibly causing skin penetration, irritation, fibrosis, necrosis, and/or pain. Bursitis. Tissue or nerve dam-age caused by improper positioning and placement of implants or instruments.

5. Post-operative change in spinal curvature, loss of correction, height, and/or reduction.6. Infection.7. Dural tears, pseudomeningocele, fistula, persistent CSF leakage, meningitis.8. Loss of neurological function (e.g., sensory and/or motor), including paralysis (complete or incomplete),

dysesthesias, hyperesthesia, anesthesia, paresthesia, appearance of radiculopathy, and/or the developmentor continuation of pain, numbness, neuroma, spasms, sensory loss, tingling sensation, and/or visualdeficits.

9. Cauda equina syndrome, neuropathy, neurological deficits (transient or permanent), paraplegia, paraparesis,reflex deficits, irritation, arachnoiditis, and/or muscle loss.

10. Urinary retention or loss of bladder control or other types of urological system compromise.11. Scar formation possibly causing neurological compromise or compression around nerves and/or pain.12. Fracture, microfracture, resorption, damage, or penetration of any spinal bone (including the sacrum, pedi-

cles, and/or vertebral body) and/or bone graft or bone graft harvest site at, above, and/or below the level ofsurgery. Retropulsed graft.

13. Herniated nucleus pulposus, disc disruption or degeneration at, above, or below the level of surgery.14. Non-union (or pseudarthrosis). Delayed union. Mal-union.15. Cessation of any potential growth of the operated portion of the spine.16. Loss of or increase in spinal mobility or function.17. Inability to perform the activities of daily living.18. Bone loss or decrease in bone density, possibly caused by stresses shielding.19. Graft donor site complications including pain, fracture, or wound healing problems.20. Ileus, gastritis, bowel obstruction or loss of bowel control or other types of gastrointestinal system com-

promise.21. Hemorrhage, hematoma, occlusion, seroma, edema, hypertension, embolism, stroke, excessive bleeding,

phlebitis, wound necrosis, wound dehiscence, damage to blood vessels, or other types of cardiovascularsystem compromise.

22. Reproductive system compromise, including sterility, loss of consortium, and sexual dysfunction.23. Development of respiratory problems, e.g. pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.24. Change in mental status.25. Death.Note: Additional surgery may be necessary to correct some of these potential adverse events.

WARNING AND PRECAUTIONS:WARNING: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal con-ditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditionsare significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to degener-ative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kypho-sis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of this device for anyother conditions are unknown.

PRECAUTION: The implantation of pedicle screw spinal systems should be performed only by experienced spinalsurgeons with specific training in the use of this pedicle screw spinal system because this is a technically demand-ing procedure presenting a risk of serious injury to the patient.

A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery wheremany extenuating circumstances may compromise the results. This device system is not intended to be the solemeans of spinal support. Use of this product without a bone graft or in cases that develop into a non-union willnot be successful. No spinal implant can withstand body loads without the support of bone. In this event, bend-ing, loosening, disassembly and/or breakage of the device(s) will eventually occur.

Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and properselection and placement of the implants are important considerations in the successful utilization of the systemby the surgeon. Further, the proper selection and compliance of the patient will greatly affect the results. Patientswho smoke have been shown to have an increased incidence of non-unions. These patients should be advised ofthis fact and warned of this consequence. Obese, malnourished, and/or alcohol abuse patients are also poor can-didates for spine fusion. Patients with poor muscle and bone quality and/or nerve paralysis are also poor candi-dates for spine fusion.

PHYSICIAN NOTE: Although the physician is the learned intermediary between the company and the patient, theimportant medical information given in this document should be conveyed to the patient.

Important Information on the CD HORIZON® Spinal System

Page 30: CD HORIZON SEXTANT Rod Insertion System Surgical Technique · Rod Insertion Instrumentation works well regardless of the grafting technique chosen. I hope you find the CD HORIZON

CAUTION: FEDERAL LAW (USA) RESTRICTS THESE DEVICES TO SALE BY OR ON THE ORDER OF A PHYSI-CIAN.

Other preoperative, intraoperative, and postoperative warnings and precautions are as follows:

IMPLANT SELECTION:The selection of the proper size, shape and design of the implant for each patient is crucial to the success of theprocedure. Metallic surgical implants are subject to repeated stresses in use, and their strength is limited by theneed to adapt the design to the size and shape of human bones. Unless great care is taken in patient selection,proper placement of the implant, and postoperative management to minimize stresses on the implant, suchstresses may cause metal fatigue and consequent breakage, bending or loosening of the device before the heal-ing process is complete, which may result in further injury or the need to remove the device prematurely.

DEVICE FIXATION:In cases where a percutaneous posterior approach is used refer to the CD HORIZON® SEXTANT™ surgicaltechnique.

MEDTRONIC SOFAMOR DANEK CD HORIZON® Spinal System instrumentation contains 4.5 mm, 5.5mm and/or6.35mm rods and implants, which are intended to be used with device specific instruments.

For self breaking plugs, always hold the assembly with the Counter Torque device. Tighten and break-off the headof the plug to leave the assembly at optimum fixation security. After the upper part of the self breaking plug hasbeen sheared off, further re-tightening is not necessary and not recommended. The head part should not remainin the patient. AFTER THE UPPER PART OF THE SELF BREAKING PLUG HAS BEEN SHEARED OFF, RE-ADJUST-MENT IS NOT POSSIBLE UNLESS THE PLUG IS REMOVED AND REPLACED WITH A NEW ONE.

When using DTT Transverse Links, the M6 plug should be tightened to between 8 and 9 Nm. (70 to 80 inch-lbs).

PREOPERATIVE:1. Only patients that meet the criteria described in the indications should be selected.2. Patient conditions and/or predispositions such as those addressed in the aforementioned contraindications

should be avoided.3. Care should be used in the handling and storage of the implant components. The implants should not be

scratched or otherwise damaged. Implants and instruments should be protected during storage, especiallyfrom corrosive environments.

4. An adequate inventory of implants should be available at the time of surgery, normally a quantity in excessof what is expected to be used.

5. Since mechanical parts are involved, the surgeon should be familiar with the various components beforeusing the equipment and should personally assemble the devices to verify that all parts and necessaryinstruments are present before the surgery begins. The CD HORIZON® Spinal System components(described in the DESCRIPTION section) are not to be combined with the components from another manu-facturer. Different metal types should never be used together.

6. All components and instruments should be cleaned and sterilized before use. Additional sterile componentsshould be available in case of an unexpected need.

INTRAOPERATIVE:1. Extreme caution should be used around the spinal cord and nerve roots. Damage to the nerves will cause

loss of neurological functions.2. Breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or

operative personnel.3. The rods should not be repeatedly or excessively bent. The rods should not be reverse bent in the same loca-

tion. Use great care to insure that the implant surfaces are not scratched or notched, since such actions mayreduce the functional strength of the construct. If the rods are cut to length, they should be cut in such away as to create a flat, non-sharp surface perpendicular to the midline of the rod. Cut the rods outside theoperative field. Whenever possible, use pre-cut rods of the length needed.

4. Whenever possible or necessary, an imaging system should be utilized to facilitate surgery.5. To insert a screw properly, a guide wire should first be used, followed by a sharp tap.

Caution: Be careful that the Guide-wire, if used, is not inserted too deep, becomes bent, and/or breaks.Ensure that the Guide-wire does not advance during tapping or screw insertion. Remove the Guide-wire andmake sure it is intact. Failure to do so may cause the guide wire or part of it to advance through the boneand into a location that may cause damage to underlying structures. Do not over tap or use a screw that iseither too long or too large. Over tapping or using an incorrectly sized screw may cause nerve damage, hem-orrhage, or the other possible adverse events listed elsewhere in this package insert.

6. Bone graft must be placed in the area to be fused and graft material must extend from the upper to the lowervertebrae being fused.

7. To assure maximum stability, two or more CROSSLINK® plates or DTT Transverse Links on two bilaterallyplaced, continuous rods, should be used whenever possible.

8. Bone cement should not be used because the safety and effectiveness of bone cement has not been deter-mined for spinal uses, and this material will make removal of the components difficult or impossible. Theheat generated from the curing process may also cause neurologic damage and bone necrosis.

9. Before closing the soft tissues, provisionally tighten (finger tighten) all of the nuts or screws, especiallyscrews or nuts that have a break-off feature. Once this is completed go back and firmly tighten all of thescrews and nuts. Recheck the tightness of all nuts or screws after finishing to make sure that none loos-ened during the tightening of the other nuts or screws. Failure to do so may cause loosening of the othercomponents.

POSTOPERATIVE:The physician’s postoperative directions and warnings to the patient, and the corresponding patient compliance,are extremely important.

1. Detailed instructions on the use and limitations of the device should be given to the patient. If partial weight-bearing is recommended or required prior to firm bony union, the patient must be warned that bending,loosening and/or breakage of the device(s) are complications which may occur as a result of excessive orearly weight-bearing or muscular activity. The risk of bending, loosening, or breakage of a temporary inter-nal fixation device during postoperative rehabilitation may be increased if the patient is active, or if thepatient is debilitated or demented. The patient should be warned to avoid falls or sudden jolts in spinal posi-tion.

2. To allow the maximum chances for a successful surgical result, the patient or devices should not be exposedto mechanical vibrations or shock that may loosen the device construct. The patient should be warned ofthis possibility and instructed to limit and restrict physical activities, especially lifting and twisting motionsand any type of sport participation. The patient should be advised not to smoke tobacco or utilize nicotineproducts, or to consume alcohol or non-steroidals or anti-inflammatory medications such as aspirin duringthe bone graft healing process.

3. The patient should be advised of their inability to bend or rotate at the point of spinal fusion and taught tocompensate for this permanent physical restriction in body motion.

4. Failure to immobilize a delayed or non-union of bone will result in excessive and repeated stresses on theimplant. By the mechanism of fatigue, these stresses can cause the eventual bending, loosening, or break-age of the device(s). It is important that immobilization of the spinal surgical site be maintained until firmbony union is established and confirmed by roentgenographic examination. If a state of non-union persistsor if the components loosen, bend, and/or break, the device(s) should be revised and/or removed immedi-ately before serious injury occurs. The patient must be adequately warned of these hazards and closelysupervised to insure cooperation until bony union is confirmed.

5. As a precaution, before patients with implants receive any subsequent surgery (such as dental procedures),prophylactic antibiotics may be considered, especially for high-risk patients.

6. The CD HORIZON® Spinal System implants are temporary internal fixation devices. Internal fixation devicesare designed to stabilize the operative site during the normal healing process. After the spine is fused, thesedevices serve no functional purpose and may be removed. While the final decision on implant removal is,of course, up to the surgeon and patient, in most patients, removal is indicated because the implants are notintended to transfer or support forces developed during normal activities. If the device is not removed fol-lowing completion of its intended use, one or more of the following complications may occur: (1) Corrosion,with localized tissue reaction or pain; (2) Migration of implant position, possibly resulting in injury; (3) Riskof additional injury from postoperative trauma; (4) Bending, loosening and breakage, which could makeremoval impractical or difficult; (5) Pain, discomfort, or abnormal sensations due to the presence of thedevice; (6) Possible increased risk of infection; (7) Bone loss due to stress shielding; and (8) Potentialunknown and/or unexpected long term effects such as carcinogenesis. Implant removal should be followedby adequate postoperative management to avoid fracture, re-fracture, or other complications.

7. Any retrieved devices should be treated in such a manner that reuse in another surgical procedure is notpossible. As with all orthopedic implants, the CD HORIZON® Spinal System components should never bereused under any circumstances.

PACKAGING:Packages for each of the components should be intact upon receipt. If a loaner or consignment system is used,all sets should be carefully checked for completeness and all components including instruments should be care-fully checked to ensure that there is no damage prior to use. Damaged packages or products should not be used,and should be returned to MEDTRONIC SOFAMOR DANEK.

CLEANING AND DECONTAMINATION:Unless just removed from an unopened Medtronic Sofamor Danek package, all instruments and implants mustbe disassembled (if applicable) and cleaned using neutral cleaners before sterilization and introduction into a ster-ile surgical field or (if applicable) return of the product to Medtronic Sofamor Danek. Cleaning and disinfecting ofinstruments can be performed with aldehyde-free solvents at higher temperatures. Cleaning and decontaminationmust include the use of neutral cleaners followed by a deionized water rinse.

Note: certain cleaning solutions such as those containing formalin, glutaraldehyde, bleach and/or other alkalinecleaners may damage some devices, particularly instruments; these solutions should not be used. Also, manyinstruments require disassembly before cleaning.

All products should be treated with care. Improper use or handling may lead to damage and/or possible improp-er functioning of the device.

STERILIZATION:Unless marked sterile and clearly labeled as such in an unopened sterile package provided by the company, allimplants and instruments used in surgery must be sterilized by the hospital prior to use. Remove all packagingmaterials prior to sterilization. Only sterile products should be placed in the operative field. For a 10-6 SterilityAssurance Level, these products are recommended to be steam sterilized by the hospital using one of the threesets of process parameters below:

NOTE: Because of the many variables involved in sterilization, each medical facility should calibrate and verify thesterilization process (e.g., temperatures, times) used for their equipment. *For outside the United States, somenon-U.S. Health Care Authorities recommend sterilization according to these parameters so as to minimize thepotential risk of transmission of Creutzfeldt-Jakob disease, especially of surgical instruments that could come intocontact with the central nervous system.

Remove all packaging materials prior to sterilization. Use only sterile products in the operative field.

PRODUCT COMPLAINTS:Any Health Care Professional (e.g., customer or user of this system of products), who has any complaint or whohas experienced any dissatisfaction in the product quality, identity, durability, reliability, safety, effectiveness and/orperformance, should notify the distributor or MEDTRONIC SOFAMOR DANEK. Further, if any of the implanted CDHORIZON® Spinal System component(s) ever “malfunctions”. (i.e., does not meet any of its performance speci-fications or otherwise does not perform as intended), or is suspected of doing so, the distributor should be noti-fied immediately. If any MEDTRONIC SOFAMOR DANEK product ever “malfunctions” and may have caused orcontributed to the death or serious injury of a patient, the distributor should be notified immediately by telephone,fax or written correspondence. When filing a complaint please provide the component(s) name, part number, lotnumber(s), your name and address, the nature of the complaint, and notification of whether a written report forthe distributor is requested.

FURTHER INFORMATION:In case of complaint, or for supplementary information, or further directions for use of this system, pleasesee the address below.

IN THE USA IN EUROPE

Customer Service Division Tele: (33) 3.21.89.50.00MEDTRONIC SOFAMOR DANEK or (33) 1.49.38.80.001800 Pyramid PlaceMemphis, Tennessee 38132 USA Fax: (33) 3.21.89.50.09Telephone: 800-876-3133

or 901-396-3133 MEDTRONIC SOFAMOR DANEK International**13, rue de la Pedtrix93290 TREMBLAY EN FRANCEFRANCE

**authorized EC representative

©2003 MEDTRONIC SOFAMOR DANEK USA, INC. All rights reserved.

METHOD CYCLE TEMPERATURE EXPOSURE TIMESteam Pre-Vacuum 270° F (132° C) 4 MinutesSteam Gravity 250° F (121° C) 30 MinutesSteam* Gravity* 273° F (134° C)* 20 Minutes*

Page 31: CD HORIZON SEXTANT Rod Insertion System Surgical Technique · Rod Insertion Instrumentation works well regardless of the grafting technique chosen. I hope you find the CD HORIZON

ROD INSERTION SYSTEM

For product availability, labeling limitations and/or more information on any Medtronic Sofamor Danek USA, Inc. products, contact your MEDTRONIC SOFAMOR DANEK USA, INC. SalesAssociate, or call MEDTRONIC SOFAMOR DANEK USA, INC. Customer Service toll free: (800) 933-2635. ©2003 MEDTRONIC SOFAMOR DANEK, INC. All Rights Reserved.

LITSEXTST02 REV.C 6/03

MINIMAL ACCESS SPINAL TECHNOLOGIESSM

MEDTRONIC SOFAMOR DANEK USA, INC.1800 Pyramid Place Memphis, TN 38132

(901) 396-3133 (800) 876-3133Customer Service: (800) 933-2635

www.sofamordanek.com

The CD HORIZON

ECLIPSE System is an

exciting innovation in

scoliosis management

that allows for

expedited patient

rehabilitation as well

as a greatly improved

cosmetic result.

The CD HORIZON

SEXTANT System has

opened new realms of

opportunity in minimally

invasive pedicle screw

fixation, that provide

greater options for

physicians and patients

than ever before.

The METRx System

allows surgeons to treat

herniated discs using a

revolutionary technique

that drastically reduces

scarring and provides

for a rapid return to

normal activity.

C D H O R I Z O N ®