Initial two level acdf was performed on (b)(6) 2014 to fuse c5-c7 vertebral bodies.During a follow up visit; (b)(6) 2015, it was noted that the bone screw at c7 had backed out from the plate.Revision surgery was performed on (b)(6) 2015 and the bone screw was removed and replaced.The remaining hardware (plate and screws) were left in-situ.The patient is reportedly doing well post revision surgery.Patient's activity level, compliance with post-surgical instructions or if the patient sustained some impact or fall are unknown.
|
(b)(4).Radiograph was received.The film is somewhat indistinct, however the screw appears to be loosened.Though the screw was removed and replaced, the hospital will not relinquish the device at this time.No product information was given, no product returned and no further evaluation of the product can be completed at this time.Patient bone quality is unknown.The root cause of this reported event has not been determined; no conclusion can be drawn.
|