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.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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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Device report from (b)(6) reports an event as follows: it was reported that (b)(6) 2021 the patient underwent an unknown cranial procedure.The screws were placed into an instrument case in order so they could be selected correctly during the procedure.When the upper case of the instrument case was removed some of the screws stuck and were raised together.The screws almost fell off from the upper case.Concomitant device: unk - cases/trays/modules(part# unknown, lot# unknown, qty unknown).This report is for one (1) ti matrixneuro screw self-drilling 4mm.This is report 1 of 1 for (b)(4).
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