Product complaint # : (b)(4).Additional product code : hwc ktw.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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.Product was not returned.Based on the information available, it has been determined that no corrective and 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) 2021, the patient underwent for a removal surgery.During the surgery, four (4) 2.7mm cortex screw self-tapping 16mm, two (2) 2.7mm cortex screw-tapping 18mm and one (1) 2.7mm lc-dcp plate 6 holes were removed due to pain.No fragments generated.There was no surgical delay.The procedure successfully completed.The patient outcome was unknown.This complaint seven (7) devices.This report is for (1) 2.7mm cortex screw self-tapping 18mm.This report is 2 of 7 (b)(4).
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