valiant anterior lumbar plate - zimmer biomet€¦ · implant features ... plate’s screw holes....

Surgical Technique

Valiant™ AnteriorLumbar Plate

A low profile solution for anterior surgery

• SphereLock™screwlockingtechnologydesignedtopreventscrewbackoutandmaximizesloadsharing

• Taperedplatedesignallows foreasierplateplacementintightspaces

Introduction ................................................ Page 1

Indications .................................................. Page 1

Implant Features .........................................

Instruments ................................................ Page 4

SurgicalTechnique ..................................... Page 6

Implant Removal ......................................... Page 11

IndicationsforUse ...................................... Page 11

ProductInformation .................................... Page 12

DescriptionofDevice .................................. Page 13

Contents

InstructionsforUse .................................... Page 13

Contraindications ........................................ Page 14

Warnings .................................................... Page 14

Precautions ................................................. Page 15

PotentialAdverseEffectsandComplications ...................................... Page 16

Sterilization ................................................. Page 16

FurtherInformation ..................................... Page 17

1

Introduction Indications

TheValiant ™AnteriorLumbarPlateSystemisacomplete

setofimplantsandinstrumentsdesignedforanterior

stabilizationofthelumbarspine.TheValiant ™ Anterior

LumbarPlateSystemislowprofileandtaperedtofitthe

naturalcontoursofthelowerlumbaranatomy.

Thesystemfeatures:

• NovelSphereLock ™lockingtechnologymaking screwplacementsimpleandsecure

• Sacralplatesfordirectanteriorplacementbelow thebifurcationofthegreatvessels

• Lumbarplatesforanteriororanterolateralplacement dependingonthelocationofthebifurcationofthe

great vessels

TheValiant ™AnteriorLumbarPlateSystemisananterioror

anterolateralspinalfixationdeviceindicatedforusevialateral

oranterolateralsurgicalapproachabovethebifurcationofthe

greatvesselsoranteriorapproach,belowthebifurcationof

thegreatvesselsinthefusionofthelumbarorlumbosacral

spineatlevelsL1throughS1.Thesystemisindicated

foruseinthetemporarystabilizationoftheanteriorspine

duringthedevelopmentofsolidspinalfusionsinpatients

withdegenerativediscdisease(asdefinedbybackpainof

discogenicoriginwithdegenerationofthediscconfirmedby

patienthistoryandradiographicstudies),traumaincluding

fractures,tumors,deformity(definedaskyphosis,lordosisor

scoliosis),pseudoarthrosis,spondyloysis,spondylolisthesis,

stenosisand/orfailedpreviousfusion.

2

Implant Features

Plate Specifications:

• SphereLock ™lockingtechnologyisdesignedtoprevent screwbackout

• Lowprofile(2.5mm)

• Twopre-bentlordoticoptions - Lumbar:100mm - Lumbosacral:50mm

• Smoothedgesandcontouredanglesguardagainst damagetosurroundinganatomy

• Availableinlengths33mm–45mm (2.0mmincrements)

• Madeoftitaniumalloy(Ti-6Al-4VELI)

• Tapereddesignallowsinsertionintightspaces

10°ConvergentScrewAngle

LengthsMeasuredFromPlateTopEdgetoBottomEdge

Radius:100mm

LumbarPlate

Radius:50mm

LumbosacralPlate

3

Screw Specifications:

• Diameters - 5.5mm - 6.25mm

• Availablein20mm–34mmlengths (2.0mmincrements)

• Coarsethreadpitchforcancellousbonepurchase

• Self-tappingtoeaseinsertion

• Blunttipscrewpoint

• Pentalobeself-retainingscrewdriverinterface

LengthsMeasuredFromBaseofHead toScrewTip

SphereLock ™ LockingThreads

SelfTapping ScrewPoint

5.5mm Diameter Screw

6.25mm Diameter Screw

4

Short Guide Inserter/Remover (14-530251)

Quick“couples”orconnectstoShort2”drillguide

(14-530250)toaidguideinsertionandremoval.

Temporary Tack (14-530249)

UsedthroughtheThreadedDrillGuidetoprovisionallysecure

theplatetothebone.

• UsedalongwithTemporary Tack Inserter (14-530248)

Screw Remover (14-530219)

Centering Post (14-530240)

Insertsintoplateholestohelpalignthreadeddrillguides.

Threaded Drill Guide

Threadsontoplate.EnsurespropertrajectoryofAwls,Drills

andScrews.AvailableinShort2”(14-530250)andStandard

12”(14-530215)lengths.

Instruments

5

Pentalobe Screwdriver Shaft, self retaining (14-530218)

UsedwithRatchetingHandle(14-530239)forscrew

insertion.AlsousedwithTorqueLimitingHandle

(14-530220),forfinaltightening.

Straight Ratchet Handle (14-530226)

Torque Limiting Handle (14-530220)

70in.lbs.

Mallet (14-530935)

Alsofunctionsasaslaphammer.

Awl (14-530216)

UsedwiththeThreadedDrillGuidestobreakthroughthe

cortexofthevertebralbody.

Drill (14-530217)

UsedwiththeThreadedDrillGuides.

6

Step3

Option 1

Surgical Technique

Step 1

Aftersurgicalexposureandimplantationofautograft,

allograftorclearedinterbodydevice,removeanyvisible

osteophytessotheplatecanlieflushonthevertebralbodies.

Step 2 – Plate Size Selection

Selecttheappropriateplatesizesothatitbridgesthe

intervertebralspaceandthescrewholeslieclosetoboth

inferiorandsuperiorvertebralendplates.

NOTE:Theblue50mmcurvedpre-bentlumbosacral

platesaredesignedforuseatL5-S.Thegold100mm

curvedpre-bentlumbarplatesaredesignedforL1-L5.

WARNING:Bendingtheplateisnotrecommended.

Theplateholescandeform,compromisingthescrew

lockingmechanism,andscrewtrajectory.

Step 3 – Plate Attachment

Option 1 – Standard Drill Guide

Whilethedesiredlengthplateisintheplatesterilization

caddy,insertthecenteringpost(14-530240)intooneofthe

plate’sscrewholes.Oncethecenteringpostispositioned,

thestandarddrillguide(14-530215)isthenslidoverthe

centeringpostandthreadedintotheplate.Afterthestandard

drillguideissecuredtotheplate,removethecenteringpost.

Repeatstepsforremainingthreestandarddrillguides.

Onceattachedthedrillguidesmaybeusedasaplate

holderforpositioningonthespine.

7

Step3–Option2

Option 2 – Short Drill Guide

Whilethedesiredlengthplateisintheplatesterilization

caddy,insertthecenteringpost(14-530240)intooneofthe

plate’sscrewholes.Oncethecenteringpostispositioned,the

shortdrillguide(14-530250)isthenslidoverthecentering

postandthreadedintotheplate.Aftertheshortdrillguideis

securedtotheplate,removethecenteringpost.Attachthe

remainingthreeshortorstandarddrillguidesinasimilar

manner.Theshortguideinserter/remover(14-530251)can

thenbeattachedtooneoftheshortdrillguidesandusedas

aplateholderforpositioningonthespine.

8

Step 4 – Plate Positioning

Positiontheplatesothatthescrewscanbeimplantedclose

tothevertebralendplates.

Step 5 – Provisional Plate Fixation

Provisionallyfixtheplateontothebonebyinsertingthe

TemporaryTacks(14-530249)throughtheDrillGuides.

ItisrecommendedthatTacksareplacedincontralateral

screwholes.LightimpactionwithaMallet(14-530935)

maybenecessary.

Surgical Technique (Continued)

9

Step 6 – Hole Preparation

WhileplateisinpositioninserttheAwl(14-530216)through

theDrillGuidetoperforatethecorticalbone.Themaximum

awlpenetrationthroughthedrillguideis20mm.Fluoroscopy

canbetakenatthispointtodeterminetheappropriate

screwlength.

IfnecessarytheDrill(14-530217)canalsobeusedtofurther

preparethecorticalboneforscrewinsertion.Themaximum

penetrationforbothofusedinstrumentsthroughthedrill

guideis20mm.

Step 7 – Screw Selection

Selecttheappropriatelength5.5mmdiameterscrew.

Screwlengthsrangefrom20mm–34mmin2.0mm

increments.6.25mmdiameterscrewsarealsoavailable

asarescuescrew.

NOTE:Screwsarecolorcodedbylength.

20mm 22mm 24mm 26mm

28mm 30mm 32mm 34mm

10

Surgical Technique (Continued)

Step 8 – Insert Screws

UsetheSelf-RetainingPentalobeScrewDriver(14-530218)

toinsertthescrewthroughthedrillguideandthreadintoa

preparedhole.

RemoveanyTemporaryTack(s)andrepeatstepsfor

remainingscrewhole(s).

Step 9 – Final Tightening/Seating

AttachtheTorqueLimitingHandle(70in.lbs)(14-530220)

toPentalobeScrewDriver(14-530218).Anaudibleclickwill

beheardwhenthescrewhasreachedpropertorque.

NOTE:FinalseatingwiththetorquelimitingT-handleisonly

doneafterallscrewshavebeeninserted,andthreadedto

theplate.

11

Implant Removal Indications for Use

TheValiant™AnteriorLumbarPlateSystemisananterior

oranterolateralspinalfixationdeviceindicatedforusevia

thelateraloranterolateralsurgicalapproachabovethe

bifurcationofthegreatvesselsorviatheanteriorsurgical

approach,belowthebifurcationofthegreatvesselsin

thefusionofthelumbarorlumbosacralspineatlevelsL1

throughS1.Thesystemisindicatedforuseinthetemporary

stabilizationoftheanteriorspineduringthedevelopment

ofsolidspinalfusionsinpatientswithdegenerativedisc

disease(asdefinedbybackpainofdiscogenicoriginwith

degenerationofthediscconfirmedbypatienthistoryand

radiographicstudies),traumaincludingfractures,tumors,

deformity(definedaskyphosis,lordosisorscoliosis),

pseudoarthrosis,spondyloysis,spondylolisthesis,stenosis

and/orfailedpreviousfusion.

Theplateandscrewscanberemovedwiththesame

instrumentationthatwasusedtoimplantthem.Reattachthe

drillguidetotheplate.Usethestraighthandlewiththescrew

drivershaftandplacedownthedrillguidetoengagethe

screw.Thedrivermaythenbeturnedinacounterclockwise

fashionuntilthescrewisdisengagedandremoved.Repeat

thisprocessonallfourscrewholesthenremovetheplate.

Ifnecessary,thescrewremovershaftmaybeusedinthe

pentaloberecessofthescrew.Attachthescrewremover

shafttothestraighthandleandrotatecounter-clockwiseinto

thecompromisedpentaloberecessofthescrew.Thescrew

removershaftwillretainthescrewasthescrewisunthreaded

fromtheplate.

ScrewRemover(14-530225)

12

Product Information

Implant

Catalog # Description

14-530150 LumbarPlate,33mm(Gold)







14-530160 LumbosacralPlate,33mm(Blue)







14-530190 5.5mmx20mmPentalobeScrew
















Instrument


14-530215 DrillGuide-Standard

14-530216 Awl-Standard

14-530217 Drill-Standard

14-530218 PentalobeScrewDriver-Standard

14-530219 ScrewRemover-Standard

14-530220 TorqueHandle

14-530226 RatchetingStraightHandle

14-530240 CenteringPost

14-530225 ScrewRemover

14-530248 TackInserter

14-530249 PlateTacks

14-530250 ShortGuide(2")

14-530251 ShortGuideInserter/Remover

14-530935 SlottedMallet

Loaner Kit


14-530227 InstrumentLoanerKit

14-530228 ImplantLoanerKit

13

Description of Device Instructions for Use

CAUTION:TheValiant ™AnteriorLumbarPlateSystemshould

onlybeimplantedbysurgeonswhoarefullyexperiencedin

theuseofsuchimplantsandtherequiredspecializedspinal

surgicaltechniques.

TheValiant ™AnteriorLumbarPlateSystemisasupplemental

fixationsystemconsistingofavarietyofshapesandsize

ofplatesandscrews.TheValiant ™AnteriorLumbarPlateis

availableincurvaturesof50mmand100mmwithlengths

from33mmto45mm.Thescrewsfeaturealockingheadand

areavailableindiametersof5.5mmand6.25mminlengths

of20mmto34mm.TheValiant ™AnteriorLumbarPlate

Systemismadefromtitaniumalloy(Ti-6Al-4VELI)described

byASTMStandardF136.

14

Contraindications Warnings

Contraindicationsinclude,butarenotlimitedto,

1. Infection,systemic,spinalorlocalized;

2. Morbidobesity;

3. Signsoflocalinflammation;

4. Feverorleukocytosis;

5. Metalsensitivity/allergiestotheimplantmaterials;

6. Anymedicalorsurgicalconditionwhichwouldpreclude

thepotentialbenefitofspinalimplantsurgery,suchas

theelevationofsedimentationrateunexplainedbyother

diseases,elevationofwhitebloodcount(WBC)ora

markedleftshiftintheWBCdifferentialcount;

7. Grosslydistortedanatomyduetocongenital

abnormalities;

8. Rapidjointdisease,boneabsorption,osteopenia,and/or

osteoporosis(osteoporosisisarelativecontraindication

sincethisconditionmaylimitthedegreeofobtainable

correction,theamountofmechanicalfixation,and/orthe

qualityofthebonegraft);

9. Anycasenotneedingabonegraftandfusionorwhere

fracturehealingisnotrequired;

10. Anycaserequiringthemixingofmetalsfrom

differentcomponents;

11. Anypatienthavinginadequatetissuecoverageoverthe

operativesiteorwherethereisinadequatebonestock,

bonequality,oranatomicaldefinition;

12.Anycasenotdescribedintheindications;

13. Anypatientunwillingtocooperatewiththepostoperative

instructions;

14. Anytimeimplantutilizationwouldinterfere

withanatomicalstructuresorexpected

physiologicalperformance.

Thesurgeonshouldbeawareofthefollowing:

1. Thecorrectselectionoftheimplantisextremely

important.Thepotentialforsuccessisincreasedbythe

selectionofthepropersize,shapeanddesignofthe

implant.Thesizeandshapeofthehumanspinepresents

limitingrestrictionsofthesizeandstrengthofimplants.

2. Thesurgeonmustensurethatallnecessaryimplants

andinstrumentsareonhandpriortosurgery.Thedevice

mustbehandledandstoredcarefully,protectedfrom

damage,includingfromcorrosiveenvironments.

Theyshouldbecarefullyunpackedandinspectedfor

damagepriortouse.

3. Allinstrumentsmustbecleanedandsterilizedprior

to surgery.

4. Aswithallorthopaedicimplants,theValiant ™ Anterior

LumbarPlateSystemshouldneverbereusedunderany

circumstances.

5. Properimplantselectionandpatientcomplianceto

post-operativeprecautionswillgreatlyaffectsurgical

outcomes.Patientswhosmokehavebeenshowntohave

anincreasedincidenceofnonunion.Therefore,these

patientsshouldbeadvisedofthisfactandwarnedofthe

potentialconsequences.

6. Postoperativecareisimportant.Thepatientshouldbe

instructedinthelimitationsofhis/herimplantandshould

becautionedregardingweightbearingandbodystress

ontheappliancepriortosecurebonehealing.

15

Precautions

Preoperative

Onlypatientsthatmeetthecriteriadescribedintheindications

shouldbeselected.Patientconditionsand/orpre-dispositions

suchasthoseaddressedintheContraindicationsSection

shouldbeavoided.Careshouldbeusedinthehandlingand

storageoftheimplantcomponents.Theimplantsshould

notbescratchedorotherwisedamaged.Implantsand

instrumentsshouldbeprotectedduringstorageespecially

fromcorrosiveenvironments.Allinstrumentsshouldbe

cleanedandsterilizedbeforeuse.

Intraoperative

Anyinstructionmanualsshouldbecarefullyfollowed.Atall

times,extremecautionshouldbeusedaroundthespinalcord

andnerveroots.Damagetonervesmayoccurresultingina

lossofneurologicalfunctions.Bonegraftsmaybeplacedin

theareatobefused.

Postoperative

Thephysician’spostoperativedirectionsandwarningsto

thepatientandthecorrespondingpatientcomplianceare

extremelyimportant.Detailedinstructionsontheuseand

limitationsofthedeviceshouldbegiventothepatient.

Ifpartialweight-bearingisrecommendedorrequired

priortofirmbonyunion,thepatientmustbewarnedthat

bending,looseningorbreakageofthecomponentsare

complicationswhichcanoccurasaresultofexcessiveor

earlyweight-bearingorexcessivemuscularactivity.Therisk

ofbending,loosening,orbreakageofaninternalfixation

deviceduringpostoperativerehabilitationmaybeincreasedif

thepatientisactive,orifthepatientisdebilitated,demented,

orotherwiseunabletousecrutchesorothersuchweight

supportingdevices.

Thepatientshouldbewarnedtoavoidfallsorsuddenjoltsin

spinalposition.Toallowmaximumchancesforasuccessful

surgicalresult,thepatientordeviceshouldnotbeexposedto

mechanicalvibrationsthatmayloosenthedeviceconstruct.

Thepatientshouldbewarnedofthispossibilityand

instructedtolimitandrestrictphysicalactivities,especially

lifting,twistingmotionsandanytypeofsportparticipation.

Thepatientshouldbeadvisednottosmokeorconsume

alcoholduringthebonegrafthealingprocess.Ifanonunion

developsorifthecomponentsloosen,bend,and/orbreak,

thedevice(s)shouldberevisedand/orremovedimmediately

beforeseriousinjuryoccurs.Failuretoimmobilizeadelayed

ornonunionofbonewillresultinexcessiveandrepeated

stressesontheimplant.Bythemechanismoffatiguethese

stressescancauseeventualbending,loosening,orbreakage

ofthedevice(s).Itisimportantthatimmobilizationofthe

spinalsurgicalsitebemaintaineduntilfirmbonyunionis

establishedandconfirmedbyradiographicexamination.

Thepatientmustbeadequatelywarnedofthesehazardsand

closelysupervisedtoensurecooperationuntilbonyunion

isconfirmed.Anyretrieveddevicesshouldbetreatedin

suchamannerthatreuseinanothersurgicalprocedureis

notpossible.Aswithallorthopaedicimplants,noneofthe

Valiant™AnteriorLumbarPlateSystemcomponentsshould

everbereusedunderanycircumstances.

16

Potential Adverse Effects and Complications Sterilization

Possibleadverseeffectsinclude,butarenotlimitedto,

1. Bending,looseningorfractureoftheimplants

orinstruments;

2. Lossoffixation;

3. Sensitivitytoametallicforeignbody,includingpossible

tumorformation;

4. Skinormusclesensitivityinpatientswithinadequate

tissuecoverageovertheoperativesite,whichmayresult

inskinbreakdownand/orwoundcomplications;

5. Nonunionordelayedunion;

6. Infection;

7. Nerveorvasculardamageduetosurgicaltrauma,

includinglossofneurologicalfunction,duraltears,

radiculopathy,paralysisandcerebralspinalfluidleakage;

8. Gastrointestinal,urologicaland/orreproductivesystem

compromise,includingsterility,impotencyand/orloss

ofconsortium;

9. Painordiscomfort;

10. Bonelossduetoresorptionorstressshielding,orbone

fractureat,aboveorbelowthelevelorsurgery(fracture

ofthevertebra);

11.Hemorrhageofbloodvesselsand/orhematomas;

12. Malalignmentofanatomicalstructures,includingloss

ofproperspinalcurvature,correction,reduction

and/orheight;

13.Bursitis;

14.Bonegraftdonorsitepain;

15.Inabilitytoresumeactivitiesofnormaldailyliving;

16. Reoperation or

17.Death.

TheValiant ™AnteriorLumbarPlateSystemis

providednonsterileandmustbesterilizedpriorto

use.Allpackagingmaterialsmustberemovedpriorto

sterilization.Thefollowingsteamsterilizationparameters

arerecommended.

Cycle:HighVacuum

Temperature:270°F/132°C

Time:8minutes

NOTE:Allowforcooling.Individualsnotusingthe

recommendedmethod,temperatureandtimeareadvisedto

validateanyalternativemethodsorcyclesusinganapproved

methodofstandard.

CAUTION:Federal(USA)lawrestrictsthesedevicestosaleby

orontheorderofalicensedphysician.

17

Further Information

Thisbrochuredescribesthesurgicaltechniqueusedby

CharlesBanta,MD,FrankKuwamura,MD,VikasPatel,MD,

andJohnGorup,MD.Thesurgeonwhoperformsanyimplant

procedureisresponsiblefordeterminingtheappropriate

products(s)andutilizingtheappropriatetechnique(s)forsaid

implantationineachindividualpatient.Thecontentsofthis

manualareintendedtobeonlyaguideandarenotintended

tosetastandardofcare.

Forfurtherinformation,pleasecontacttheCustomer

ServiceDepartmentat:

BiometSpine

100InterpaceParkway

Parsippany,NJ07054

973.299.9300•800.526.2579

www.biometspine.com

18

Notes:

19

Notes:

20

Notes:

AtBiomet,engineeringexcellenceisourheritageand

ourpassion.Forover25years,throughvarious

divisionsworldwide,wehaveappliedthemost

advancedengineeringandmanufacturingtechnology

tothedevelopmentofhighlydurablesystemsfora

widevarietyofsurgicalapplications.

Tolearnmoreaboutthisproduct,

contactyourlocalBiometSalesRepresentativetoday.

Valiant™ Anterior Lumbar PlateA low profile solution for anterior surgery

100InterpaceParkway•Parsippany,NJ07054800.526.2579•www.biometspine.com•BSP216555L10/10

©2010EBI,LLC.AlltrademarksarethepropertyofBiomet,Inc.oroneofitssubsidiariesunlessotherwiseindicated.RxOnly.

valiant anterior lumbar plate - zimmer biomet€¦ · implant features ... plate’s screw holes....

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