Trauma patient in or.Patient had 2 procedures, rib plating and orif for ulnar fracture from mva.Device used to secure screws came apart vs.Failed at end of procedure for rib plating.Device rep called to notify and advise.Primary surgeon well familiar with device (been using it for 8+ years and actually trialed device when in (b)(6)).Operating room felt all pieces were accounted for.Nothing found in thoracic cavity.Second surgeon came in to complete orif of ulna.Chest x-ray ordered after closure at end of both procedures to confirm chest tube placement and lung status.X-ray significant for foreign object in subcutaneous tissue.Surgeon notified.Patient reopened for removal of rfo.Patient was not removed from the operating room and was not extubated from initial procedure.Fda safety report id# (b)(4).
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