510k: this report is for an unknown plate/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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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It was reported that on an unknown date the patient underwent an unknown surgical procedure for fracture fixation of acetabulum, utilizing two (2) spring plates and one (1) recon plate.Postoperatively, the patient had deep peroneal nerve palsy (did not have pre-op).It is unknown if there was a surgical delay reported.No further information is available.This report is for one (1) unknown plate.This is report 2 of 4 for (b)(4).
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