Patient¿s height reported as (b)(6).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.
|
It was reported that an unknown procedure was performed on an unknown date where a patient was implanted with one (1) 4.5 condylar plate, two (2) 4.5 cortex screws, six (6) locking screws and two (2) 1.7 cables.Post-operatively, the patient fell and it was discovered via x-ray on an unknown date that the 4.5 condylar plate broke.Revision surgery was performed on (b)(6) 2017 where all implants were removed and patient was implanted with new hardware.Procedure was completed successfully with no surgical delay and patient status was reported as stable.X-rays are not available.Concomitant devices reported: unknown 4.5 cortex screws (part# unknown, lot# unknown, quantity 2), unknown 5.0 locking screws (part# unknown, lot# unknown, quantity 6), unknown 1.7 cables (part# unknown, lot# unknown, quantity 2).This report addresses the revision surgery due to postoperative broken plate.The intraoperative issue of screw breakage during revision surgery has been captured under related complaint (b)(4).This report is for one (1) 4.5mm lcp curved condylar plate 16 holes/350mm-left.This is report 1 of 1 for complaint (b)(4).
|