Product complaint # (b)(4).This report is for an unk - biomaterial - cement: vertecem v+/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.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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Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra) patient who underwent depuy synthes uss pedicle screws used with vertecem+.The following complications have been identified as per the spine tango report: interop adverse events: dural lesion.Postoperative general complications: pulmonary, cerebral, liver/gi, other.Postop surgical before discharge: motor dysfunction, wound infection superficial, wound infection deep.Reoperation: instability.This report is for a depuy synthes uss pedicle screws used with vertecem+.This report is for (1) unk - biomaterial - cement: vertecem v+ this report is 2 of 4 for (b)(4).
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