Surgical Technique
Trinnect™ Hydrated Anterior Cervical Spacer System
• Preservon†retainsmechanicalstrengthbyeliminatingthepotentialbrittlenessassociatedwithfreezedrying
• Load-bearingcorticaledgesprovidestructuralintegritywhilethelargecancellouscenterallowsforosteointegration
• Readyforuseinunder30secondswithouttheneedforrehydration
B
Contents
Introduction................................................ Page1
ProductOverview(DesignFeatures).......... Page1
FeaturesandBenefits.................................. Page2
Instruments................................................ Page3
SurgicalTechnique..................................... Page4
IndicationsforUse...................................... Page7
OrderingInformation.................................. Page8
FurtherInformation..................................... Page9
1
Trinnect™AllograftSpacersarecomposedofcorticalbonefor
structuralintegrityanddensecancellousboneforintegration.
Thegraftfeaturestwopiecesofcorticalbonetoformthe
lateralaspectsofthegraftwithcancellousboneinthecenter.
ThefootprintoftheTrinnect™Spacermeasures14.5mm
widewithadepthof11.5mm.Availableheightsrangefrom
5mmto12mmin1mmincrements.Thespacerfeatures7°of
lordosistocloselyapproximatethecurvatureofthecervical
spine.Inaddition,eachgraftismachinedwithhorizontal
ridgestoprovideexpulsionresistance.
Cancellous
Cortical Cortical
Introduction Product Overview (Design Features)
TheTrinnect™HydratedAnteriorCervicalSpacerSystemisa
lineofprecision-machinedcervicalallograftspacers.
Trinnect™AllograftSpacersareprocessedbyLifeNetHealth†,
whichisaccreditedbytheAmericanAssociationofTissue
Banks(AATB).Trinnect™AllograftSpacersarepackaged
usingPreservon†,aglycerol-basedpreservationtechnology,
allowingthespacertobestoredinafullyhydratedstateat
ambienttemperature,eliminatingtheneedtofreezeor
freeze-drythespacers.
2
Features and Benefits
• Preservon†retainsmechanicalstrengthbyeliminatingthepotentialbrittlenessassociatedwithfreezedrying
• Load-bearingcorticaledgesprovidestructuralintegritywhilethelargecancellouscenterallowsforintegration
• Readyforuseinunder30secondswithouttheneedforrehydration
3
Instruments
TheTrinnect™HydratedAllograftimplantsetoffersaunique
setofinstrumentationthatissimpletouseanddesigned
withtheintentofmakingadirectcontributiontosuccessful
clinicalresults.
Slotted Mallet Head
Trial with Stops
Trial without Stops
Rasp with Stops
Rasp without Stops
Cervical Spacer Inserter
5mm Tamp
4
Surgical Technique
Usingastandardsurgicalapproach,exposethevertebral
bodiestobefused.Traditionalcervicalretractorsmaybe
used.Preparethefusionsitefollowingtheappropriate
techniqueforthespecificindication.
Step 1: Vertebral Body Distraction
Ifusingdistractionpins,placeonedistractionpininthe
vertebralbodysuperiortotheaffectedlevelandtheother
distractionpininthevertebralbodyinferiortotheaffected
level.Thepindistractorisplacedoverthepinsandopenedas
neededtodistractthevertebralbodies.
Step 2: Discectomy and End-Plate Preparation
Usingrongeurs,pituitariesandcurettes,removethe
intervertebraldiscandosteophytesasneeded.Rasps
canalsobeusedtopreparetheendplatesandexpose
bleedingbone.
Thetrialsandraspsaredouble-sidedforefficiency.These
instrumentscorrespondtotheimplantfootprintsandare
availablein5mm–12mmheightsin1mmincrementssimilar
totheimplants.Theraspsaredesignedsothattheteethcut
onthebackstrokeastheinstrumentisbeingpulledaway
fromthespinalcord.
CAUTION:Aggressivepreparationoftheendplatemay
removeexcessiveboneandweakentheendplate.
5
Step 3: Implant Sizing
Usingthedouble-sidedraspsortrials,determinethe
appropriateimplantsizebysizingthediscspace.When
sizing,useincrementallylargersizesuntilatightfitis
achieved.Asecurefitisdesirabletomaintaindischeightand
stabilizethesegment.Thereshouldbenogapsbetweenthe
preparedsizeandtrialorrasp.
Thetrialsandraspsarebothavailablewithorwithoutstops.
Thestopsallowforamaximumof2mmofcountersinkinto
thediscspace.
Oncethedesireddischeightisdetermined,selectthe
appropriateTrinnect™implant.
Step 4: Implant Insertion
Loadthegraftontotheinserterbyplacingitbetweenthe
tinesandturntheknobattheproximalendoftheinserter
clockwisetofullyengagetheimplant.
Introducetheimplantintothevertebraldiscspaceusingthe
inserter.Theimplantshouldbethesameheightasthesize
determinedbythetrialandshouldbeseatedsecurelywithin
thediscspace.Taptheproximalstrikeplateoftheinserter
withamallettogentlyseattheimplant.Theimplantmaybe
insertedflushwiththeanteriorrimoftheadjacentvertebral
bodiesormaybecountersunkpasttheanteriorrimatthe
physician’sdiscretion.
6
Disengagetheimplantfromtheinserterandremove
theinstrument.Thetampmaybeutilizedtofurther
advancetheimplantintothediscspaceifdesired.
RepeatstepstoinsertadditionalTrinnect™Spacer
Systemimplantsatadditionalintervertebrallevels.
Proceedwiththeapplicationofanteriorcervical
instrumentationandclosure.
Surgical Technique (Continued)
7
Description
Thisallograftspacerwasprocessedfromdonatedhuman
tissue,resultingfromthegenerousgiftofanindividualor
his/herfamily.Thespacerwascleanedanddisinfected
throughaproprietaryprocessandterminallysterilizedvia
gammairradiation.
Therearetwopreservationmethodsincludedinthese
instructions:Freeze-Dried,andpackagedwithPreservon†.
Pleaserefertothelabeltoidentifywhichpreservationmethod
wasutilizedforthisspacer.
Indications for Use
Thisallograftspacerisintendedforimplantation.
Contraindications
Thecontraindicationsinclude,butarenotlimitedto:
• Useinanypatientwhohasaknownorsuspectedallergy toanyoftheantibioticsand/orprocessingreagentslisted
inthispackageinsert
Warnings and Precautions
Thesamemedical/surgicalconditionsorcomplications
thatapplytoanysurgicalproceduremayoccurduring
orfollowingimplantation.Thesurgeonisresponsiblefor
informingthepatientoftherisksassociatedwiththeir
treatmentandthepossibilityofcomplicationsoradverse
reactions.Aswithanyallograftspacer,thetransmissionof
infectiousagentsexists.
Thisspacermaycontainresidualsofantibiotics(Bacitracin,
Gentamicin,and/orPolymyxinBSulfate),alcohol,
surfactants,and/orglycerol.Cautionshouldbeexercisedif
thepatienthasaknownsensitivitytoanyoftheseantibiotics
and/orreagents.
Potential Adverse Events
Potentialadverseeventsoroutcomesinclude,butarenot
limitedto,diseasetransmission,infection,allografttissue
rejection,allergicreactiontoresidualprocessingreagents,
reoperationand/ordeath.
Promptlyreportanyadverseevent(s)oroutcome(s)
potentiallyattributabletotheallograftspacer.
Safety
Alldonorshavebeenscreenedandtissuesrecovered,
processed,stored,testedanddistributedinaccordancewith
currentU.S.federalregulationsaspromulgatedin21CFR
1270and1271,currentStandardsforTissueBankingset
forthbytheAATBandinternationallawsandregulations
asrequired.Moreinformationcanbefoundinthedonor
screeningandtestingsectionofthepackageinsert.
Indications for Use
8
Ordering Information
Trinnect™ Hydrated Anterior Cervical Allograft Implant Kit
(Catalog No. 14-531209)
Catalog # Description Qty/Set
LNHC05 Hydrated5mmLordoticCervicalGraft
2
LNHC06 Hydrated6mmLordoticCervicalGraft
3
LNHC07 Hydrated7mmLordoticCervicalGraft
4
LNHC08 Hydrated8mmLordoticCervicalGraft
4
LNHC09 Hydrated9mmLordoticCervicalGraft
4
LNHC10 Hydrated10mmLordoticCervicalGraft
3
LNHC11 Hydrated11mmLordoticCervicalGraft
2
LNHC12 Hydrated12mmLordoticCervicalGraft
2
Trinnect™ Hydrated Anterior Cervical Allograft Instrument
Kit (Catalog No. 14-531208)
Catalog # Description Qty/Set
14-531640 Trial5/6Hx14Wx12DwithStops
1
14-531641 Trial7/8Hx14Wx12DwithStops
1
14-531642 Trial9/10Hx14Wx12DwithStops
1
14-531643 Trial11/12Hx14Wx12DwithStops
1
14-531750 Trial5/6Hx14Wx12DwithoutStops
1
14-531751 Trial7/8Hx14Wx12DwithoutStops
1
14-531752 Trial9/10Hx14Wx12DwithoutStops
1
14-531753 Trial11/12Hx14Wx12DwithoutStops
1
14-531830 Rasp5/6Hx14Wx12DwithStops
1
14-531831 Rasp7/8Hx14Wx12DwithStops
1
14-531832 Rasp9/10Hx14Wx12DwithStops
1
14-531833 Rasp11/12Hx14Wx12DwithStops
1
14-531890 Rasp5/6Hx14Wx12DwithoutStops
1
14-531891 Rasp7/8Hx14Wx12DwithoutStops
1
14-531892 Rasp9/10Hx14Wx12DwithoutStops
1
14-531893 Rasp11/12Hx14Wx12DwithoutStops
1
14-531141 CervicalSpacerInserter 2
14-531142 5mmTamp 1
14-531563 SlottedMalletHead 1
9
Further Information
Allcontenthereinisprotectedbycopyright,trademarksand
otherintellectualpropertyrightsownedbyorlicensedto
BiometInc.oritsaffiliatesunlessotherwiseindicated,and
mustnotberedistributed,duplicatedordisclosed,inwhole
orinpart,withouttheexpresswrittenconsentofBiomet.
Thismaterialisintendedforhealthcareprofessionalsand
theBiometsalesforce.Distributiontoanyotherrecipient
isprohibited.
Forcompleteproductinformation,includingindications,
contraindications,warnings,precautions,andpotential
adverseeffects,seethepackageinsert.
Thistechniquewaspreparedinconjunctionwithalicensed
healthcareprofessional.Biometdoesnotpracticemedicine.
Thetreatingsurgeonisresponsiblefordeterminingthe
appropriatetreatment,technique(s),andproduct(s)foreach
individualpatient.
Forfurtherinformation,pleasecontacttheCustomerService
Departmentat:
BiometSpine
310InterlockenParkway,Suite120
Broomfield,CO80021
303.443.7500or800.447.3625
biometspine.com
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©2014BiometSpine,LLC.Allrightsreserved.AlltrademarksarethepropertyofBiomet,Inc.,oroneofitssubsidiaries,unlessotherwiseindicated.†Denotesathirdpartytrademark.RxOnly.
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Trinnect™ Hydrated Anterior Cervical Spacer System