FDA Adverse Event
Other
Summary report: N
X STOPPK IPD SYSTEM
MDR report key: 799484
·
Received December 20, 2006
Report
- Report Number
- 2953720-2006-00011
- Event Type
- Other
- Date Received
- December 20, 2006
- Date of Event
- November 15, 2006
- Report Date
- December 20, 2006
- Manufacturer
- ST. FRANCIS MEDICAL TECHNOLOGIES, INC.
- Product Code
- NQO
- PMA / PMN Number
- p040001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. CONCLUSION: OTHER: NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
A SPINOUS PROCESS FRACTURE WAS REPORTED TO OCCUR DURING A SURGICAL PROCEDURE IN WHICH A 12 MM X STOP PK IPD WAS TO BE IMPLEMENTED AT THE L4-L5 LEVEL. THE IMPLANT WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | X STOPPK IPD SYSTEM | INTERSPINOUS PROCESS PROSTHESIS | NQO | ST. FRANCIS MEDICAL TECHNOLOGIES, INC. | 1-3012 | 060925 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |