FDA Adverse Event
Other
Summary report: N
LUMBER INTERBODY FUSION SYSTEM
MDR report key: 497732
·
Received November 25, 2003
Report
- Report Number
- 2184052-2003-00021
- Event Type
- Other
- Date Received
- November 25, 2003
- Date of Event
- December 8, 1998
- Report Date
- November 25, 2003
- Manufacturer
- CENTERPULSE SPINE-TECH
- Product Code
- MAX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
IN 1998, PT HAD L5-S1 DISCECTOMY AND FUSION WITH TWO 17 X 24MM BAD/PROXIMITY CAGES, PART # 8001-1724-00, LOT # P970114. AT SOME POINT IN 2000, PT HAD SURGERY TO REMOVE THE BAK CAGES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUMBER INTERBODY FUSION SYSTEM | BAK/PROXIMITY IMPLANT | MAX | CENTERPULSE SPINE-TECH | NA | P970114 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |