It was reported that a two level pdc implantation occurred approximately (b)(6) 2023.Following implantation, the patient experienced on-going arm pain and weakness.A two level removal occurred on (b)(6) 2023 and the patient was converted to a two level acdf with a cage and plate system.The removing surgeon indicated that inadequate decompression led to the ongoing patient symptoms.A review of the dhr could not be completed as the part number and lot number were not provided and could not be determined during the investigation.Complaint trending found that the rate of complaints was within the rates outlined in the risk documentation.A review of the risk documentation found that the risks associated with the complaint are identified and mitigated to a level where the benefits of the surgery outweigh the risks.Device evaluation could not be completed as the hospital would not release the implants following the removal surgery, additionally pre-removal x-ray images were not available.No device anomalies were identified during the investigation, the removal surgery was due to ongoing patient symptoms caused by inadequate decompression during the implantation surgery.This submission is 2 of 2 devices involved in this event.
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