FDA Adverse Event
Other
Summary report: N
LUMBAR I/F CAGE SYSTEM
MDR report key: 386094
·
Received April 4, 2002
Report
- Report Number
- 1526439-2002-00018
- Event Type
- Other
- Date Received
- April 4, 2002
- Date of Event
- March 22, 2002
- Report Date
- April 4, 2002
- Manufacturer
- DEPUY ACROMED, INC.
- Product Code
- JDQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO DEPUY ACROMED THAT A LUMBAR CAGE BROKE POST-OPERATIVELY. FURTEHR INFORMATION FROM THE COMPLAINANT REVEALED THAT THE CAGE ACTUALLY ROTATED AND WAS NOT BROKEN. A REVISION SURGERY WAS REQUIRED TO RE-POSITION THE CAGE. IT WAS ALSO REPORTED THAT THE CAGE WAS USED BY ITSELF (NO POSTERIOR FIXATION) AND PLACED AT AN OBLIQUE ANGLE. THERE WERE NO OTHER ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LUMBAR I/F CAGE SYSTEM | LUMBAR CAGE | JDQ | DEPUY ACROMED, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |