Production process analysis: 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 (b)(6) 2024 apifix was notified that patient (b)(6) (pas (b)(6) who was a patient in dayton is planned to be converted to fusion in another facility (north carolina) by another physician.On (b)(6) 2024 additional information was received.According to the reporter, "the patient's kyphosis has gotten so bad.In addition, the patient's curves are still progressing to about 50°.It is unsure at this time when the patient is having the fusion." 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 the explanted device is expected to be returned to the manufacturer and will be evaluated; upon its completion, once new information comes to light, then a supplemental medwatch report will be submitted.
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