low profi le neuro plating systemsynthes.vo.llnwd.net/o16/llnwmb8/us mobile/synthes...313.931 low...
TRANSCRIPT
Low Profi le Neuro Plating SystemSurgical Technique
SystemSurgical TechniqueSurgical Technique
Low Prof le Neuro Plating System Surgical Technique DePuy Synthes 1
TABLE OF CONTENTS
INTRODUCTION
SURGICAL TECHNIQUE
PRODUCT INFORMATION
Low Profile Neuro Plating System 2
Technique 5
Low Profile Neuro Plates 10
Low Profile Neuro Mesh 12
Instruments 13
Modules and Trays 15
MR Information The Low Profile Neuro Plating System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration or image artifact in the MR environment. The safety of the Low Profile Neuro Plating System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.
2 DePuy Synthes Low Prof le Neuro Plating System Surgical Technique
LOW PROFILE NEURO PLATING SYSTEM
IntroductionThe aim of surgical fracture treatment is to reconstruct the bony anatomy and restore its function. According to the AO, internal fixation is distinguished by precise reduction, stable fixation, preservation of blood supply, and early mobilization.1 Plate and screw osteosynthesis has been established and clinically recognized for some time.
The Low Profile Neuro Plating System is a cranial closure system that features low plate/screw profile, wide variety of implants, and modular storage options.
Warnings: • Not intended for use in patients who are not yet
skeletally mature. Resorbable fixation products should be considered as an alternative.
• These devices can break during use (when subjected to excessive forces or outside the recommended surgical technique). While the surgeon must make the final decision on removal of the broken part based on associated risk in doing so, we recommend that whenever possible and practical for the individual patient, the broken part should be removed.
• Be aware that implants are not as strong as native bone. Implants subjected to substantial loads
may fail.
Precaution: Surgical implants must never be reused. An explanted metal implant must never be reimplanted. Even though the device appears undamaged, it may have small defects and internal stress patterns which could lead to breakage.
1. Müller ME, Allgöwer M, Schneider R, Willenegger H. Manual of Internal Fixation, 3rd Edition. Berlin: Springer-Verlag. 1991.
Low Prof le Neuro Plating System Surgical Technique DePuy Synthes 3
LOW PROFILE NEURO PLATING SYSTEM
Featuresx Low plate-and-screw profi le for decreased palpabilityx Self-drilling,* self-retaining screws, with modifi ed
cruciform recess, facilitate rapid replacement of bone fl ap
x Wide variety of low-profi le plates to repair the most common types of bony defects and fractures
x Modular storage options to meet specifi c surgeon needs
0.60 mm 0.75 mm 0.90 mm
Low Profile DePuy Synthes DePuy SynthesNeuro† 1.3 mm 1.5 mm
Low-profi le constructx Variety of plates to meet specifi c patient and
surgeon needs
Low-profi le meshx Available in a wide variety of shapes and sizesx Rigid (0.6 mm thick, silver) and malleable
(0.4 mm thick, blue) meshx Design allows screw placement through either
side of meshx Available nonsterile or sterile-packed
*Self-tapping screws are also available.† Data on file.
IndicationsDePuy Synthes Low Profi le Neuro System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla and chin.
4 DePuy Synthes Low Prof le Neuro Plating System Surgical Technique
Low Profile Neuro Plating System
*Self-tapping screws are also available.† Mechanical test data on file at DePuy Synthes. Mechanical test results are not necessarily indicative of clinical performance.
Self-drilling screwsx Screws are self-drilling* for easy, one-step insertionx Made from titanium alloy (Ti-6Al-7Nb)x Modified cruciform recess provides:
– High-torque capacity† – Optimal screw retention for quick and easy insertion of screws† – Low-profile rigid fixation†
x Available in 3 mm–6 mm lengths
Hex coupling screwdriver handlesx Available in 3 sizes, including a large ergonomic handlex Hexagonal coupling for easy blade insertion
and removal
311.006
311.007
311.005
Low Prof le Neuro Plating System Surgical Technique DePuy Synthes 5
SURGICAL TECHNIQUE
1Select implant
Select the appropriate implants depending on use. The Low Profile Neuro Plating System contains a wide variety of plates, burr hole covers, mesh, and screws.
Precaution: When using plates, ensure countersink holes are facing upward.
2Size implant (if required)
Instrument
391.952 Mesh Cutter
Implants may be cut and sized to match the patient anatomy.
Replace worn or damaged cutting instruments if the cutting function is not adequate.
Precautions: • Take care to protect soft tissue from trimmed edges. • Replace worn or damaged cutting instruments if
the cutting function is not adequate. • Cut the implant immediately adjacent to the
screw holes.
1 DePuy Synthes Low Prof le Neuro Plating System Surgical Technique
3Contour implant (if required)
Instrument
329.14 Universal Bending Pliers (two required)
The implant can be contoured to match the patient’s anatomy.
Precaution: Excessive and repetitive bending of the implant increases the risk of implant breakage.
4Position implant
Instrument
348.98 Plate Holding Forceps, Locking
Position the implant on the desired location using the appropriate plate holder.
Surgical Technique
Low Prof le Neuro Plating System Surgical Technique DePuy Synthes 1
Surgical Technique
5Pre-drill screw holes (optional)
Instruments
316.624 1.1 mm Drill Bit, hex coupling, 4 mm stop, 52 mm
316.626 1.1 mm Drill Bit, hex coupling, 6 mm stop, 52 mm
317.14 1.1 mm Drill Bit, Stryker J-Latch coupling, 4 mm stop, 44.5 mm
317.16 1.1 mm Drill Bit, Stryker J-Latch coupling, 6 mm stop, 44.5 mm
6Secure implant
Instruments
313.931 Low Profile Neuro Cruciform Screwdriver Blade, hex coupling, self-retaining, short
313.932 Low Profile Neuro Cruciform Screwdriver Blade, hex coupling, self-retaining, medium
311.005 Screwdriver Handle, hex coupling, small
311.006 Screwdriver Handle, hex coupling, medium
311.007 Screwdriver Handle, hex coupling, large
To load the screw onto the blade, place the blade perpendicular to the screw in the module and fully insert the blade into the screw recess. The screw should be securely attached to the blade.
Precautions: • DePuy Synthes recommends pre-drilling in dense
bone when using 5 mm or 6 mm screws. Drill rate should never exceed 1,800 rpm. Higher rates can result in thermal necrosis of the bone, soft tissue burns, and an oversized hole to be drilled. The adverse effects of an oversized hole include reduced pullout force, increased ease of screws stripping in bone, and/or suboptimal fi xation.
• Irrigate during drilling to avoid thermal damage to the bone.
• Handle devices with care and dispose worn bone cutting instruments in a sharps container.
• Use only a 1.3 mm drill bit for pre-drilling.
8 DePuy Synthes Low Prof le Neuro Plating System Surgical Technique
For optimal plate/screw profile, insert the screw perpendicular to the plate/bone in the appropriate plate hole. If the screw does not obtain purchase, replace it with a blue Low Profile Neuro emergency screw of the same length.
Screwdriver shafts are self-retaining. Replace screwdriver shafts if they are worn or damaged, or if retention is not adequate.
Precautions: • Fully engage the shaft perpendicular to the
screw head. • Place the 1.6 mm self-drilling screw perpendicular
to the bone at the appropriate plate hole. Take care not to over tighten the screw.
• In order to determine the appropriate amount of fixation for stability, the surgeon should consider the size and shape of the fracture or osteotomy. DePuy Synthes recommends at least three plates when repairing osteotomies. Additional fixation is recommended to ensure stability of large fractures and osteotomies. When using mesh for larger defects, additional screws for fixation are recommended.
• After implant placement is complete, discard any fragments or modified parts in an approved sharps container. Irrigate and apply suction for removal of debris potentially generated during implantation.
Surgical Technique
Low Prof le Neuro Plating System Surgical Technique DePuy Synthes 9
1
2
3
Notes:• Secure the implants to the bone flap before
positioning the bone flap on the patient.
1. Secure the desired plates to bone flap.2. Position the bone flap.3. Secure the plates to the skull.
In order to determine the appropriate amount of fixation for stability, the surgeon should consider the size and shape of a fracture or osteotomy.
Precautions:• DePuy Synthes recommends at least three plates
when repairing osteotomies. Additional fixation is recommended to ensure stability of large fractures and osteotomies. When using mesh for larger defects, additional screws for fixation are recommended.
• After implant placement is complete, discard any fragments or modified parts in an approved sharps container. Irrigate and apply suction for removal of debris potentially generated during implantation.
Surgical Technique
10 DePuy Synthes Low Prof le Neuro Plating System Surgical Technique
LOW PROFILE NEURO PLATES
421.502 Titanium Low Profi le Neuro Straight Plate, 2 holes, 12 mm
Also available in 2 holes, 9 mm, see page 18
421.510 Titanium Low Profi le Neuro X-Plate, 4 holes
421.511 Titanium Low Profi le Neuro Box Plate,14 mm x 14 mm
Also available in 10 mm x 16 mm and 16 mm x 16 mm, see page 18
421.504 Titanium Low Profi le Neuro Straight Plate, 4 holes
421.525 Titanium Low Profi le Neuro Burr Hole Cover, 12 mm diameter
Also available in 15 mm, 17 mm, and 24 mm, see page 18
421.554 Titanium Low Profi le Neuro Burr Hole Cover, for shunt, 17 mm diameter
Also available in 15 mm, see page 18
Low Prof le Neuro Plating System Surgical Technique DePuy Synthes 11
Low Profile Neuro Plates
421.515 Titanium Low Profile Neuro Y-Plate,5 holes
421.516 Titanium Low Profile Neuro Double Y-Plate, 6 holes, 18 mm
Also available in 6 holes, 21 mm, see page 18
421.519 Titanium Low Profile Neuro Adaption Plate, 7 holes
Also available in 5 holes and 20 holes, see page 18
421.523 Titanium Low Profile Neuro Strut Plate,2 x 4 holes
Also available in 2 x 3 holes, see page 18
421.501 Titanium Low Profile Neuro Contourable Strut Plate, 8 holes
12 DePuy Synthes Low Prof le Neuro Plating System Surgical Technique
LOW PROFILE NEURO MESH
421.500 Titanium Low Profi le Neuro Temporal Mesh Plate, malleable, medium
421.543 Titanium Low Profi le Neuro Contourable Mesh, 30 mm diameter, silver, 0.6 mm rigid
Also available in other shapes and sizes, see page 18
421.540 Titanium Low Profi le Neuro Contourable Mesh, 30 mm diameter, blue, 0.4 mm malleable
Also available in other shapes and sizes, see page 18
421.546 Titanium Low Profile Neuro Contourable Mesh, mastoid, large, blue, 0.4 mm, malleable
Also available in medium, see page 18
Low Prof le Neuro Plating System Surgical Technique DePuy Synthes 13
INSTRUMENTS
313.932 Low Profile Neuro Cruciform Screwdriver Blade, self-retaining, hex coupling, medium
329.14 Universal Bending Pliers (two required)
391.952 Mesh Cutter
313.931 Low Profile Neuro Cruciform Screwdriver Blade, self-retaining, hex coupling, short
14 DePuy Synthes Low Prof le Neuro Plating System Surgical Technique
Instruments
316.624 1.1 mm Drill Bit, hex coupling, 4 mm stop, 52 mm
316.626 1.1 mm Drill Bit, hex coupling,6 mm stop, 52 mm
317.14 1.1 mm Drill Bit, Stryker J-Latch coupling, 4 mm stop, 44.5 mm
317.16 1.1 mm Drill Bit, Stryker J-Latch coupling,6 mm stop, 44.5 mm
311.006 Screwdriver Handle with hex coupling, medium
311.007 Screwdriver Handle with hex coupling, large
348.98 Plate Holding Forceps, locking
311.005 Screwdriver Handle with hex coupling, small
Low Prof le Neuro Plating System Surgical Technique DePuy Synthes 15
MODULES AND TRAYS
304.634 Low Profile Neuro Compact Module
304.674 Low Profile Neuro Standard Module
For detailed cleaning and sterilizationinstructions, please refer towww.synthes.com/cleaning-sterilization orsterilization instructions, if provided.
11 DePuy Synthes Low Prof le Neuro Plating System Surgical Technique
Modules and Trays
304.760 Universal Instrument Tray, large, deep304.761* Neuro Instrument Tray Lid, large 304.762 Neuro Insert Tray, for instruments
304.760 Universal Instrument Tray, large, deep 304.761* Neuro Instrument Tray Lid, large 304.774 Neuro Insert Tray, for Battery
Powered Screwdriver
*Lids not shown.
304.771 Universal Instrument Tray, extra large, deep
304.772* Neuro Instrument Tray Lid, extra large 304.773 Neuro Insert Tray, for cranial clamps 304.762 Neuro Insert Tray, for instruments
Low Prof le Neuro Plating System Surgical Technique DePuy Synthes 11
LOW PROFILE NEURO SYSTEM
Set, Modules, and Trays145.827 Titanium Low Profile Neuro System304.634 Low Profile Neuro Compact Module 304.634.40 Label Sheet, for Low Profile Neuro Module 304.674 Low Profile Neuro Standard Module304.760 Universal Instrument Tray, large, deep 304.761 Neuro Instrument Tray Lid, large304.762 Neuro Insert Tray, for instruments304.771 Universal Instrument Tray, extra large, deep304.772 Neuro Instrument Tray Lid, extra large304.773 Neuro Insert Tray, for cranial clamps304.774 Neuro Insert Tray, for Battery Powered Screwdriver304.775 Neuro Multi Clamp Insert Tray
Instruments 1.1 mm Drill Bits, hex coupling316.624 4 mm stop316.626 6 mm stop
1.1 mm Drill Bits, Stryker J-Latch317.14 4 mm stop317.16 6 mm stop
1.3 mm Drill Bits, Stryker J-Latch310.133 3 mm stop310.136 4 mm stop310.137 6 mm stop
1.3 mm Drill Bits, hex coupling310.134 3 mm stop310.138 4 mm stop310.139 6 mm stop
Screwdriver Handles with hex coupling311.005 Small311.006 Medium311.007 Large
Low Profile Neuro Cruciform Screwdriver Blades, self-retaining
313.931 Hex coupling, short313.932 Hex coupling, medium313.933 Mini quick coupling, short
329.14 Universal Bending Pliers348.98 Plate Holding Forceps, Locking 391.952 Mesh Cutter
Titanium Low Profile Neuro Screws Low Profile Neuro Screws, self-drilling
(with self-retaining cruciform recess) (5/pkg.)
400.833 3 mm length400.834 4 mm length400.835 5 mm length400.836 6 mm length
Low Profile Neuro Screws, self-tapping, (with self-retaining cruciform recess) (5/pkg.)
400.843 3 mm length400.844 4 mm length400.845 5 mm length400.846 6 mm length
Low Profile Neuro Emergency Screws, self-tapping, (with self-retaining cruciform recess) (5/pkg.)
400.853 3 mm length400.854 4 mm length400.855 5 mm length400.856 6 mm length
18 DePuy Synthes Low Prof le Neuro Plating System Surgical Technique
Titanium Low Profile Neuro Plates421.501 Contourable Strut Plate, 8 holes421.502 Straight Plate, 2 holes, 12 mm421.503 Straight Plate, 2 holes, 9 mm421.504 Straight Plate, 4 holes421.510 X-Plate, 4 holes421.511 Box Plate, 14 mm x 14 mm, 4 holes421.512 Box Plate, 16 mm x 16 mm, 4 holes421.515 Y-Plate, 5 holes421.516 Double Y-Plate, 6 holes, 18 mm421.517 Double Y-Plate, 6 holes, 21 mm421.518 Adaption Plate, 5 holes421.519 Adaption Plate, 7 holes421.520 Adaption Plate, 20 holes421.521 Box Plate, 10 mm x 16 mm, 4 holes421.522 Strut Plate, 6 holes421.523 Strut Plate, 8 holes
Titanium Low Profile Neuro Burr Hole Covers421.525 12 mm diameter421.526 15 mm diameter421.527 17 mm diameter421.528 24 mm diameter421.553 For shunt, 15 mm diameter421.554 For shunt, 17 mm diameter
◊ Available nonsterile or sterile-packed. Add “S” to product number for sterile product.
Low Profile Neuro System
Titanium Low Profile Neuro Contourable Mesh421.500 Temporal Titanium Mesh Plate,
malleable, medium
0.6 mm Rigid Mesh, silver◊
421.532 38 mm x 45 mm421.534 100 mm x 100 mm421.535 200 mm x 200 mm421.538 Small arc421.539 Large arc421.543 30 mm diameter421.544 70 mm diameter421.545 100 mm diameter
0.4 mm Malleable Mesh, blue◊
421.531 38 mm x 45 mm421.533 100 mm x 100 mm421.536 Small arc421.537 Large arc421.540 30 mm diameter421.541 70 mm diameter421.542 100 mm diameter421.546 Mastoid, large421.547 Mastoid, medium
Limited Warranty and Disclaimer: DePuy Synthes products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed.
Please also refer to the package insert(s) or other labeling associated with the devices identified in this surgical technique for additional information.
CAUTION: Federal Law restricts these devices to sale by or on the order of a physician.
Some devices listed in this surgical technique may not have been licensed in accordance with Canadian law and may not be for sale in Canada. Please contact your sales consultant for items approved for sale in Canada.
Not all products may currently be available in all markets.
© DePuy Synthes 2014–2017. All rights reserved.DSUS/CMF/0414/0067(1) 6/17 DV
Synthes USA, LLC 1101 Synthes AvenueMonument, CO 80132
Manufactured or distributed by:Synthes USA Products, LLC 1302 Wrights Lane EastWest Chester, PA 19380
To order (USA): 800-523-0322 To order (Canada): 855-946-8999
Note: For recognized manufacturer, refer to the product label.
www.depuysynthes.com