N
Patient 1
THE AWL WAS FOUND TO BE BENT AT THE DISTAL TIP, IT IS NOT KNOWN IF THIS WAS DUE TO THE PATIENT'S HARD BONE OR THE SURGEON'S FAILURE TO USE THE GUIDED INSTRUMENTATION THAT MUST BE USED WITH THIS SYSTEM.
MAUDE MDR 6645779
- MDR report key
- 6645779
- Report number
- 3005031160-2017-00140
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-05-02
- Date received
- 2017-06-15
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 403
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. KRISS ANDERSON
- Address
- 452 ALEXANDERSVILLE ROAD MIAMISBURG OH 45342 US
- Phone
- 937-937-9378
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | IRIX-C GUIDED ANGLE AWL | AWL | X-SPINE SYSTEMS, INC. | HWJ | T066-0061 | 67629 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-06-15 | 0 | 1. O |
Event Narratives#
D
Patient 1
DURING A REVISION SURGERY TO REMOVE NON X-SPINE CERVICAL PLATE AND REPLACE IT WITH IRIX-C IMPLANT ON ADJACENT LEVELS, THERE WERE COMPLICATIONS WITH HARD BONE. THE SURGEON USED SEVERAL TOOLS TO TRY TO START A PILOT HOLE; THE FREEHAND AWL WAS BENT, THE GUIDED ANGLED AWL WAS BROKEN, A 14MM DRILL WAS BENT, A 14MM DRILL WAS BROKEN, AND ONE STRAIGHT AWL WAS BENT. THERE WERE NO PATIENT INJURIES DUE TO THE BROKEN AND BENT INSTRUMENTS. SURGEON WAS ABLE TO START A PILOT HOLE WITH A SELF-DRILLING SCREW AFTER SEVERAL ATTEMPTS.