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 patient underwent a craniotomy with insertion of electrode array on (b)(6) 2018.While the surgeon as inserting one (1) 6mm and two (2) 8mm matrixmidface screws into the housing for the array, the screw head came off.The remaining portion of the screw remains embedded in patient¿s bone.Surgery was completed successfully with an unspecified delay.Concomitant device reported: non-synthes electrode array (part number unknown, lot number unknown, quantity 1).This report is for one (1) 6mm matrixmidface screw.This is report 1 of 3 for (b)(4).
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