Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.G4 ¿ 510k: this report is for an unknown cage/spacer: eit - tlif/unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H6: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) for the study titled: retrospective study on conduit¿ cages compared to peek cages in a transforaminal lumbar interbody fusion procedure to treat patients with degenerative disc disease.Patients included in this study were implanted with conduit¿ straight and/or curved tlif cages between october 2019 and june 2021, or with opal¿ or t-pal¿ peek interbody cages between january 2017 and april 2019.From the population of 101 patients treated with conduit straight tlif or conduit curved tlif, complications were identified as follows: infection: 1; dural tear: 4; rod fracture: 1; adjacent segment disease: 23; symptomatic screw loosening: 5; symptomatic psudeoarthrosis: 3; reoperations: 10; revisions: 3.This report involves one unk cage/spacer: eit - tlif.This is report 3 of 3 for (b)(4).
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