On july 8 2021, the university of (b)(6) medicine ((b)(6)) contacted (b)(4) regarding the removal surgery, and provided (b)(4) with a copy of form fda 3500.However, upon review of form fda 3500, completed by (b)(6), the "brand name", "common device name", "model #", "lot number were incorrect.The information provided by the hospital, via e-mail, stated: "miami device solutions proximal humerus plates"- "the implant failed in a very unusual fashion with the plate pulling off the bone through the screws with the screw heads remaining intact".
|
This event was the second revision surgery, in which the plating system was explanted on (b)(6) 2021.The x-rays provided demonstrate the two most distal screws of the plate pushed through the plate.The third most distal screw of the plate had loosened from the bone as it had migrated away from the plate, and the screws on the proximal humerus head were intact.The surgeon was able to remove the screws, plate, and locking caps without any issues.No delays or patient impact were reported.
|