FDA Adverse Event
Injury
Summary report: N
VERTE-STACK CRESCENT PEEK
MDR report key: 1020023
·
Received March 27, 2008
Report
- Report Number
- 1030489-2008-00151
- Event Type
- Injury
- Date Received
- March 27, 2008
- Date of Event
- February 27, 2008
- Report Date
- February 27, 2008
- Manufacturer
- SOFAMOR DANEK DEGGENDORF GMBH
- Product Code
- NEK
- PMA / PMN Number
- K052261
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. EVALUATION IS IN PROCESS. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SINGLE-LEVEL TLIF AT L5/S1 USING A PEEK VERTEBRAL BODY DEVICE, ALLOGRAFT AND RHBMP-2/ACS. APPROXIMATELY 2.5 MONTHS POST-OP THE VERTEBRAL BODY DEVICE WAS NOTED TO HAVE BACKED OUT AT THE ANNULOTOMY SITE, AND WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERTE-STACK CRESCENT PEEK | VB REPLACEMENT | NEK | SOFAMOR DANEK DEGGENDORF GMBH | NA | MX82 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention |