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 synthes reports an event in (b)(6) as follows: it was reported that on an unknown date during a sagittal split ramus osteotomy (ssro) procedure to treat mandibular jaw deformity, the screw was not able to be tightened against a plate.On the other hand, a replacing screw was tightened to the same plate.The procedure was completed without surgical delay.No further information is available.This report is for one (1) 2.0mm ti matrixmandible locking screw slf-tpng 6mm.This is report 1 of 1 for complaint (b)(4).
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