DIAMOND COBB ELEVATOR
Received Apr 3, 2017 · Event occurred Mar 29, 2017
Report MW5068895 · MDR key 6459781
Device
Product problems
- Break
- Detachment Of Device Component
Patient
58 YR
- Hemorrhage/Blood Loss/Bleeding
- Laceration(s)
- Foreign Body In Patient
- Hemorrhage/Blood Loss/Bleeding
- Laceration(s)
- Foreign Body In Patient
Narrative
Description of Event or Problem
A (B)(6) MALE UNDERWENT AN ANTERIOR LUMBAR INTERBODY FUSION L4-L5 AND L5-S1 LEVELS. DURING SURGERY A DIAMOND COBB ELEVATOR WAS BEING USED (BY ORTHOPEDIC SURGEON) AND WHILE MANEUVERING THE INSTRUMENT IT BROKE IN HALF WITH A RESIDUAL PART REMAINING IN THE DISK SPACE. THE REMAINING PIECE WAS REMOVED BY THE ORTHOPEDIC SURGEON, AND UPON REMOVAL, THE LEFT COMMON ILIAC VEIN AND LEFT EXTERNAL ILIAC VEIN WERE LACERATED. THIS WARRANTED A SURGICAL INTERVENTION (BY 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 1 UNIT OF PACKED CELLS IN RECOVERY. ON (B)(6) 2017- PATIENT WAS STABLE AND DISCHARGED HOME.