3.5MM LCP PROXIMAL HUMERUS PLATE SYNTHES (USA)

PT ADMITTED TO THE HOSPITAL WITH A FRACTURE AT THE LEFT PROXIMAL HUMERUS. IMPLANTED WITH A PROXIMAL HUMERUS PLATE. ONE WEEK STATUS POST ORIF LEFT HUMERUS, THE PT UNDERWENT SURGICAL DEBRIDEMENT OF HEMATOMA. INTRAOPERATIVELY, THE SURGEON FOUND THAT THE SCREWS WERE BACKING OUT INTO THE SOFT TISSUE. THE SURGEON ELECTED TO EXPLANT THE PLATE AND SCREWS AND REPLACE IT WITH ANOTHER. (THIS IS ONE OF TWO REPORTS FOR THIS EVENT).

ADDITIONAL INFO HAS BEEN REQUESTED. THE DATE OF MANUFACTURE CANNOT BE DETERMINED BECAUSE, THE LOT NUMBER IS NOT KNOWN. DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. NO CONCLUSIONS CAN BE DRAWN.