W-H ELEV DIAMOND HEAD 3/4

Additional Manufacturer Narrative

UDI: (B)(4). A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE NOT RETURNED.

Description of Event or Problem

VOLUNTARY EVENT REPORT FROM FDA ( MW5068895) A MALE PATIENT UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION L4-L5 AND L5-S1 LEVELS. DURING SURGERY, A DIAMOND COBB ELEVATOR WAS BEING USED AND WHILE MANEUVERING THE INSTRUMENT, IT BROKE IN HALF WITH A RESIDUAL PART REMAINING IN THE DISC SPACE. THE REMAINING PIECE WAS REMOVED BY THE SURGEON AND UPON REMOVAL, THE LEFT COMMON ILIAC VEIN AND LEFT EXTERNAL ILIAC VEIN WERE LACERATED. THIS WARRANTED A SURGICAL INTERVENTION BY A VASCULAR SURGEON FOR REPAIR OF BOTH LACERATED VEINS. POST REPAIR, BLEEDING WAS UNDER CONTROL AND ORTHOPEDIC SURGEON PROCEEDED WITH COMPLETION OF THE INTENDED ORTHOPEDIC PROCEDURE. PATIENT HAD ONE UNIT OF PACKED CELLS IN RECOVERY. ON (UNK DATE 2017), PATIENT WAS STABLE AND DISCHARDED HOME.