Valiant Anterior Lumbar Plate - Zimmer Biomet€¦ · Implant Features ... plate’s screw holes....
Transcript of 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 ......................................... Page 2
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
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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.
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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
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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
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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
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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.
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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.
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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.
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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)
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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
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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.
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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)
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Product Information
Implant
Catalog # Description
14-530150 LumbarPlate,33mm(Gold)
14-530151 LumbarPlate,35mm(Gold)
14-530152 LumbarPlate,37mm(Gold)
14-530153 LumbarPlate,39mm(Gold)
14-530154 LumbarPlate,41mm(Gold)
14-530155 LumbarPlate,43mm(Gold)
14-530156 LumbarPlate,45mm(Gold)
14-530160 LumbosacralPlate,33mm(Blue)
14-530161 LumbosacralPlate,35mm(Blue)
14-530162 LumbosacralPlate,37mm(Blue)
14-530163 LumbosacralPlate,39mm(Blue)
14-530164 LumbosacralPlate,41mm(Blue)
14-530165 LumbosacralPlate,43mm(Blue)
14-530166 LumbosacralPlate,45mm(Blue)
14-530190 5.5mmx20mmPentalobeScrew
14-530191 5.5mmx22mmPentalobeScrew
14-530192 5.5mmx24mmPentalobeScrew
14-530193 5.5mmx26mmPentalobeScrew
14-530194 5.5mmx28mmPentalobeScrew
14-530195 5.5mmx30mmPentalobeScrew
14-530196 5.5mmx32mmPentalobeScrew
14-530197 5.5mmx34mmPentalobeScrew
14-530200 6.25mmx20mmPentalobeScrew
14-530201 6.25mmx22mmPentalobeScrew
14-530202 6.25mmx24mmPentalobeScrew
14-530203 6.25mmx26mmPentalobeScrew
14-530204 6.25mmx28mmPentalobeScrew
14-530205 6.25mmx30mmPentalobeScrew
14-530206 6.25mmx32mmPentalobeScrew
14-530207 6.25mmx34mmPentalobeScrew
Instrument
Catalog # Description
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
Catalog # Description
14-530227 InstrumentLoanerKit
14-530228 ImplantLoanerKit
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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.
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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.
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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.
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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.
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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
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
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