Several attempts were made unsuccessfully to collect more information on this case.All that is known is that the surgeon completed two prodisc l removals on a patient with pdl implants at two levels.The patient was involved in a motor vehicle accident and as a result of the trauma experienced pdl inlay expulsion at both levels.The dates of implantation and removal are unknown.An mdr is indicated for this complaint.A review of the dhrs could not be completed as the part numbers and lot numbers were not provided and could not be determined during the investigation.Complaint trending found that the rate of complaints is within the poc level defined within the risk documentation.A review of the risk documentation found that the hazards associated with this complaint are identified and mitigated to a level where the benefits outweigh the risks.Device evaluation cannot be completed as the as the implants were not returned following the removal.It was confirmed that a removal took place due to inlay expulsion following patient trauma.No other anomalies associated with the complaint were found during the investigation.The submission is 2 of 6 devices involved in this event.
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