This report is for an unknown nail/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 procedure with retrograde approach for a poly trauma femoral shaft fracture.There was a union reported postoperatively.Postoperatively, the patient experienced an infection in the open humeral shaft fracture and returned to the operating room.There was an evidence of healing reported.No further information is available.This is report 1 of 4 for (b)(4).
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