FDA Adverse Event
Other
Summary report: N
36X11 CRESCENT CAGE
MDR report key: 2150765
·
Received June 30, 2011
Report
- Report Number
- MW5021229
- Event Type
- Other
- Date Received
- June 30, 2011
- Date of Event
- June 20, 2011
- Report Date
- June 22, 2011
- Manufacturer
- MEDTRONIC SOFMAR DANEK
- Product Code
- MAX
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PRESENTED FOR AN HAD SPINAL SURGERY COMPLETED. DURING PROCEDURE, SURGERY NOTED A BROKEN PEEK CAGE DURING INSERTION THAT REQUIRED REPLACEMENT. ALL OF BROKEN CAGE RETRIEVED BY SURGEON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 36X11 CRESCENT CAGE | MAX | MEDTRONIC SOFMAR DANEK | TZ89 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |