This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) for patients who were treated with depuy synthes spine llif.The following complications have been identified as per the spine tango report: 2 patients died.Intraop general complications: 2 complications were not documented.Intraop adverse events: 6 complications were dural lesions.2 complications were vascular injury.2 complications were fracture vertebral structures.2 were other complications.Postop general before discharge: 3 complications were cardiovascular.1 complication was pulmonary.1 complication was thromboembolism.3 complications were not documented.Postop surgical before discharge: 1 complication was sensory dysfunction.1 complication was wound infection superficial.11 were other complications.3 complications were not documented.Reoperations: 4 patients had reoperations.This report is for an unknown acis, cervios, cervios chronos, chronos, cslp, facet wedge, ecd, matrix, opal, oracle, stenofix, synapse, synex, synfix evolution, synflate, synmesh, t-pal, uss small stature, uss, uss fracture, uss fx mis, vectra, vbs, vertecem, xrl, zero-p, zero-p va.This report is for one (1) unk - cage/spacers: cervios chronos.This is report 11 of 13 for complaint (b)(4).
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This report is for an unk - cage/spacers: opal/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a j&j employee.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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