Device was used for treatment, not diagnosis.(b)(4).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient underwent an open reduction internal fixation (orif) for a periprosthetic fracture (left distal femur fracture) on (b)(6) 2016.Patient was implanted with a variable angle condylar plate, stainless steel, left, 10 hole and 5.0mm variable angle locking screws.Patient had a clinical visit on an unknown date and reported feeling good with the ability to move the knee.X-rays showed that two of the 5.0mm variable angle locking screws were backing out distally.Patient had revision surgery on (b)(6) 2016 to remove and replace the two screws.It was noted that the locking head of the two screws had become loose from the plate and backed out one cm, not providing a fixed angle construct for the patient.The two screws that were backing out were removed and five screws were added distally.The screws were easily removed without surgical delay or medical intervention.The original plate and original remaining screws were left intact in the patient.Routine x-rays standard for the procedure were taken.The plate did not appear to be stripped, as the surgeon was able to lock the five additional screws into the plate.The procedure was completed successfully.Concomitant device reported: variable angle condylar plate, stainless steel, left, 10 hole (part # unknown, lot # unknown, quantity 1).This is report number 1 of 2 for (b)(4).
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