Additional device product codes: hrs, hwc.Udi: (b)(4).Complainant device is not expected to be returned for manufacturer review/investigation.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.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 a patient initially underwent surgery on (b)(6) 2017 for a right distal femur fracture and was implanted with a 4.5mm locking compression plate (lcp) plate and 9 locking screws.During a post-operative visit, date unknown, an x-ray revealed a nonunion and that four screws were backing out of the plate.The patient was returned to the operating room on (b)(6) 2017 for the removal of the plate and nine screws and revision to a new lcp condylar plate and seven screws.It was reported that the devices were intact and easily removed.During the revision surgery the non-union site was reduced and new lcp condylar plate and seven screws were implanted.There was no delay in surgery and the patient was reported as stable.Concomitant devices: 4.5mm va-lcp curved condylar plate/6 hole/159mm/left (part# 02.124.407, lot# unknown, quantity 1), 5.0mm variable angle lockng screw/slf-tpng/strdrv/20mm (part #02.231.220, lot #unknown, quantity 2), 5.0mm variable angle lockng screw/slf-tpng/strdrv/40mm (part #02.231.240, lot #unknown, quantity 2) and 5.0mm variable angle lockng screw/slf-tpng/strdrv/60mm (02.231.260, lot #unknown, quantity 1).This report is for one (1) 5.0mm variable angle lockng screw/ slf-tpng/strdrv/80mm.This is report 4 of 4 for complaint (b)(4).
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