It was reported that a patient had a prodisc l implant placed in 2002, the pdl implant was removed on (b)(6) 2022 and the patient was fused using a fusion 4web device.No patient symptoms or hazardous situations were reported.Several unsuccessful attempts were made to gain more information about the complaint.A review of the dhr could not be completed as the part number and lot number were not reported.Complaint trending showed that the rate of complaints is at the lowest possible level of improbable.A review of the risk assessment found that the risk associated with the complaint are identified and mitigated to the lowest possible level.A device evaluation could not be completed as the implant was not returned for evaluation.It was confirmed that a prodisc l removal was completed.The investigation did not determine a cause for the removal, no device malfunction is indicated.This submission is 3 of 3 devices involved in this event.
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