Product complaint # (b)(4).Additional narrative: 510k: this report is for an unk - constructs: veptr/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 product was received; 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 related research activity database (ddra) for patients undergoing a spinal procedure using a veptr between january 2, 2006, and november 22, 2020.The mean age of the patients was 8 years.Failed spinal procedure has been identified as the reported complication as per icd 9 & 10 categorization experienced by the following with corresponding intervention: intraoperative complications: 5 patients had dural tears.1 patient had medullary injury.Reintervention during stay: 3 patients had adjustment of implants.1 patient had removal of implants.Readmission: 3 patients had adjustments of implants.2 patients had deep infections which was drained.1 patient had removal of implant.3 patients had other reasons.This is for depuy synthes veptr.This report is for one (1) unk - constructs: veptr.This is report 2 of 2 for (b)(4).
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