FDA Adverse Event
Malfunction
Summary report: N
IRIX-C GUIDED ANGLE AWL
MDR report key: 5434685
·
Received February 12, 2016
Report
- Report Number
- 3005031160-2015-00050
- Event Type
- Malfunction
- Date Received
- February 12, 2016
- Date of Event
- January 12, 2016
- Report Date
- January 13, 2016
- Manufacturer
- X-SPINE SYSTEMS, INC.
- Product Code
- HWJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
ROOT CAUSE CANNOT BE RELIABLY DETERMINED BASED ON THE INFORMATION AVAILABLE FOR EVALUATION.
Description of Event or Problem · 1
DURING AN ACDF FROM C5-C7, AS SURGEON WAS WITHDRAWING THE ANGLED AWL FROM FREEHAND GUIDE, THE AWL SNAPPED AND THE TIP WAS BROKEN OFF. PROCEDURE WAS COMPLETED USING THE STRAIGHT AWL. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION OR PATIENT INJURY. THE TIP FRAGMENT WAS RETURNED WITH THE AWL TO MANUFACTURER X-SPINE, SYSTEMS LNC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 92642 | IRIX-C GUIDED ANGLE AWL | AWL | HWJ | X-SPINE SYSTEMS, INC. | T066-0205 | EM13M002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Other |