Additional narrative: exact date of event is unknown; event occurred sometime between implantation in (b)(6)2021 and explantation on (b)(6) 2022.Complainant part is not expected to be returned for manufacturer review/investigation.Therapy date is an unknown day in (b)(6) 2021 initial reporter is a synthes sales representative device is not distributed in the united states, but is similar to device marketed in the usa.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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