(b)(6).Additional product codes: hrs and hwc.Therapy date: exact date unknown; reported as approximately 1 year prior to explant on (b)(6) 2016.Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: (b)(4).Manufacturing date: may 15, 2013.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 is reported patient was implanted with the 4.5mm variable angle (va) locking compression plate (lcp) curved condylar plate and eleven (11) screws for a fracture of the left distal femur approximately one year prior to removal.Patient presented to explant surgeon approximately two (2) weeks prior to removal with discomfort.X-rays taken on unknown date revealed the plate was broken.Patient was returned to surgery on november 15, 2016 where surgeon removed all hardware and revised patient to a new 4.5mm va lcp condylar plate and screws.Surgery was completed successfully with no delay and no harm to patient.Concomitant medical products: 5.0mm cannulated va locking screw 65mm (part number 02.231.665, lot number unknown, quantity 1), 5.0mm cannulated va locking screw 85mm (part number 02.231.685, lot number unknown, quantity 1), 5.0mm cannulated va locking screw 80mm (part number 02.231.680, lot number unknown, quantity 3), 5.0mm va locking screw 44mm (part number 02.231.244, lot number unknown, quantity 1), 5.0mm va locking screw 40mm (part number 02.231.240, lot number unknown, quantity 1), 5.0mm va locking screw 65mm (part number 02.231.265, lot number unknown, quantity 1), 5mm cannulated conical screw 75mm (part number 02.205.275, lot number unknown, quantity 1), 4.5mm cortex screw self tapping 40mm (part number 214.840, lot number unknown, quantity 1), 4.5mm cortex screw self tapping 44mm (part number 214.844, lot number unknown, quantity 1).This is report 1 of 1 for (b)(4).
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