A patient was implanted with a prodisc c vivo device at level c6-7 on (b)(6) 2023.The implant was removed on (b)(6) 2023.The patient was complaining about pain in both arms; with the right arm being worse than the left as the reason for the removal.X-ray images were provided.The surgeon stated that the implant placement looks perfect, but inadequate decompression may have occurred on the asymptomatic side.A review of of the device history record was conducted and found no anomalies.Complaint trending showed that the rate of complaints was at the lowest possible level of improbable.A review of the risk assessment found that the risks associated with the complaint are identified and mitigated to a level where the benefits outweigh the risks.A device evaluation could not be completed as the implant was disposed of at the hospital and not returned.No anomalies related to the complaint were found during the investigation.Based on the surgeon's comments, there was no malfunction of the device and the symptoms were likely caused by decompression that was not thorough enough.This submission is 1 of 1 devices involved in this event.
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