Product complaint # (b)(4).Report is for an unk - cage/spacers/bio: cervios chronos/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, it has been determined that no corrective and 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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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 acdf.The purpose of this study is to evaluate performance and safety of the cervios cage in patients undergoing acdf for degenerative conditions of the cervical spine in a period from september 2011 until february 2017.Patients were at least 18 years of age with a minimum of 12-month post-operative data available.The following complications: intraoperative complications: 7 patients had dural tear.Immediate post-op complications: 1 patient had emboli, 2 patients had hematoma.1 patient had dvt.90-day complications: 1 patient had deep vein thrombosis, 2 patients had pulmonary embolism, 10 patients had superficial infection, 4 patients had deep infection, 14 patients had new neurologic deficit, 53 patients had hoarseness (patient reported), 68 patients had dysphagia (patient reported).Reoperations due to: case 1: repeat decompression, case 2: repair of csf leak, case 3: evacuation of hematoma, case 4: evacuation of hematoma, case 5: evacuation of hematoma, case 6: evacuation of hematoma, case 7: evacuation of hematoma.This report is for an unknown synthes cervios.This report is for (1) unk - cage/spacers/bio: cervios chronos.This report is 4 of 9 for (b)(4).
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