Additional device product codes: gwo, gxr complainant part is not expected to be returned for manufacturer review/investigation occupation: reporter is a j&j sales representative.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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It was reported that on (b)(6) 2020, during an unknown procedure, it was noticed that the ten (10) ti matrixneuro self-drilling 4 mm screws were not sharp and were hard to insert.The screw heads were breaking off of the screws.Surgeon took out the screws and then redid the plating.There was a surgical delay of twenty five (25) minutes.The procedure successfully completed.The patient outcome was unknown.Concomitant devices reported: unknown screwdriver (part# unknown, lot# unknown, quantity# 1).This report is for one (1) ti matrixneuro screw self-drilling 4 mm.This is report 9 of 10 for (b)(4).
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