Product complaint # (b)(4).Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Device not available - discarded.Initial reporter is j&j company representative.Device is not distributed in the united states, but is similar to device marketed in the usa.A review of the device history records has been requested and is currently pending completion.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 synthes reports an event in (b)(6) as follows: it was reported that this was an ssro in the mandible on (b)(6) 2021.When the surgeon inserted the screw to fixate the plate (unk), the screw secured the plate less tightly than usual, a replacing screw was tightened to the plate.The procedure was completed without surgical delay as there was no harm to the patient.No further information is available.This report is for one (1) lock scr ø2 self-tap l5 tan 1u i/clip.This report is 1 of 1 for (b)(4).
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