The device was not returned to lifecell for evaluation.The internal investigation into strattice lot sp100613 included a review of the reported information, review of the device history records and review of the complaint history records.Investigation results revealed no remarkable findings with no other complaints reported against the lot and no related deviations or nonconformances revealed during processing.The lot was terminally sterilized within the process parameters and met all qc release criteria.To date, (b)(4) devices were released to finished goods and (b)(4) have been distributed.Of the (b)(4) distributed, (b)(4) have been reported as implanted.Based on our internal review with no remarkable findings, a relationship to the strattice device and this event could not be determined.Other surgical or patient factors could also contribute to this event.No further actions are required as a nonconformance could not be confirmed.
|