Patient¿s date of birth and weight are not available for reporting.Additional device product code: jey.(b)(4).Lot number unknown.Device broke intra-operatively and was not fully implanted or explanted.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 during a femoral graft to the maxilla, the surgeon was implanting three midface screws in to the bone plate which all broke at the head on (b)(6) 2017.The shafts remained implanted in the patient's bone.The heads of the screws were disposed.The surgeon used the next hole over from each broken screw and implanted additional three midface screws which were readily available.There was a one (1) minute surgical delay.There was no additional medical intervention required.Concomitant medical devices: screwdriver (part # unknown, lot # unknown, quantity 1).This report is for one (1) ti matrixmidface screw self-drilling 6mm.This is report 1 of 3 for complaint (b)(4).
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