bioMetric SpinalPak - Full Prescribing Information; INDICATIONS FOR USE; WARNINGS; PRECAUTIONS

4 5
Full Prescribing Information
INDICATIONS FOR USE
TheBiomet
®
SpinalPak
®
Non-invasiveSpineFusionStimulatorSystemisanoninvasivespinefusion
stimulatorindicatedasanadjunctelectricaltreatmenttoprimarylumbarspinalfusionsurgeryforone
ortwolevels.
WARNINGS
Cardiac pacemakers or cardioverters may be adversely affected by the Biomet
®
 SpinalPak
®
Non-invasiveSpineFusionStimulatorSystem.Theconcomitantuseofthedeviceandapacemakeror
cardiovertermustbeassessedonanindividualbasis,suchaswithanelectrocardiogram,priortouse.
Thepatientshouldbereferredtoacardiologistformonitoringofpacemakerfunctionwhilewearing
theactiveBiomet
®
SpinalPak
®
Non-invasiveSpineFusionStimulatorSystemdevice.Ifthereareany
observableadversechangesinthepacemakerrhythmoroutput,thedeviceshouldnotbeused.
ThesafetyandeffectivenessoftheBiomet
®
SpinalPak
®
Non-invasiveSpineFusionStimulatorSystem
inpregnantwomenhavenotbeenstudied,andtheeffectsofthedeviceonthemotherorthedeveloping
fetusareunknown.Apatientwhoiseitherpregnantorisintendingtobecomepregnantshouldbe
referredtoherdoctorpriortotreatmentwiththedevice.
PRECAUTIONS
ThesafetyandeffectivenessoftheBiomet
®
SpinalPak
®
Non-invasiveSpineFusionStimulatorSystem
in individuals with the following conditions have not been studied, and therefore the safety and
effectivenessofthedeviceintheseindividualsareunknown:
 – spondylitis,infection,Paget’sdisease
 – cancer,diabetesmellitus,renaldisease
 – traumaofthelumbarspine
 – osteoporosis.
Applytheelectrodesaftertheskinhasbeencleanedanddried.Iferythemadevelopsattheelectrode
sites, the electrodes should be relocated adjacent to the original sites. If the reaction does not
resolveafter48hoursafterrelocatingtheelectrodes,thepatientshouldbeinstructedtoconsultwith
thephysician.
Donotsubmerge or exposetheBiomet
®
SpinalPak
®
Non-invasiveSpine Fusion StimulatorSystem
to water. The patient must be instructed to remove the stimulator during bathing, showering
orswimming.
Compliance with the treatment schedule, daily battery pack changes, and replacing the electrodes
(1to7days)asneededareessentialforproperdevicefunction.Thissystemshouldonlybeusedwith
componentsandreplacementpartssuppliedbyBiomet.Othercomponents,partsandaccessoriesmay
notbecompatible,andmaydamagethedevice.Ifanycomponentdoesnotfunctionproperly,contact
Biomet.Noattemptshouldbemadetomodifyorrepairthedevice.
Patientsshouldbeabletousethedeviceinaccordancewiththeinstructionsforuse.If a patient cannot
comply with these instructions for any reason, use of the device is not recommended.
ADVERSE EVENTS
Duringamulti-centerclinicalstudy of 349 patientstreatedwiththe device for theindicationlisted
above,skinirritationwasthemostcommonadverseeffectassociatedwiththeuseofthedevice.It
occurredin9patients(2.6%ofthetrialpopulation):4patientstreatedwiththeactivedeviceand5
patientstreatedwiththeplacebodevice.