A review of the device history record confirmed that the device was manufactured and tested according to relevant procedures, and shipped according to manufacturer's specifications.User (surgeon and patient) information analysis: on 05-dec-2022 apifix was notified that patient # (b)(6), whose index procedure was performed on (b)(6) 2020, is scheduled for removal and fusion.The reporter alleged that the reason for the removal is 'the development of a conditional curve.Beneath the apifix.' apifix followed up with the surgeon for additional information, specifically the reason for the re-operation, as well as images of the patient's latest x-rays.The surgeon responded, noting that the reason for revision to fusion is a significant uninstrumented lumbar curve.Reoperation events are a known risk that was assessed and recorded by the product risk management file.The risk of curve progression has been assessed and found to be acceptable.The current rate for all relevant criteria (curve progression, insufficient curve correction, imbalance) is in line with the rate reported in the literature for this type of complication as described in the company's cer (clinical evaluation report).The risk has been quantified, characterized, and documented as acceptable within a full risk assessment.Apifix is closing this complaint, but will continue to monitor this 'failure mode'; complaint trending will continue to monitor per post marketing surveillance procedure.If any further relevant information is identified, the complaint file will be reopened and a supplemental medwatch will be filed.
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