(b)(6).(b)(4).Device is not expected to be returned for manufacturer review/investigation.This patient developed implant loosening, and malreduction, which resulted in additional surgical intervention.During removal surgery, the surgeon discovered infection at the implant site, and was able to remove all hardware intact.Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
|