Patient identifier, age or date of birth, and weight not available for reporting.Additional product code: jey.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part 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 pieces of the head of a matrix midface screw were disintegrating during a zygomaticomaxillary complex fracture (zmc) repair on (b)(6) 2017.A resident surgeon was implanting a 4 mm screw into the zygomatic frontal suture when the head began to break apart and disintegrate.The screw was removed successfully and no fragments remained.There was a reported ten (10) minute delay to remove and replace this screw.Another screw was used.The final construct was a midface plate and screws.The procedure was completed successfully with the patient in stable condition.Concomitant devices reported: matrixmidface orbital rim plate 12 holes 0.7 mm thick (04.503.373, lot number unknown, quantity 1), screwdriver handle with hex coupling-medium (311.006, lot number unknown, quantity 1), matrixmidface screwdriver blade hex coupling self-retaining 96 mm 03.503.203, lot number unknown, quantity 1).This report is for one (1) titanium matrixmidface screw self-drilling 4 mm.This is report 1 of 1 for (b)(4).
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