FDA Adverse Event
Other
Summary report: N
X STOP IPD SYSTEM
MDR report key: 801514
·
Received December 29, 2006
Report
- Report Number
- 2953720-2006-00018
- Event Type
- Other
- Date Received
- December 29, 2006
- Date of Event
- August 15, 2006
- Report Date
- December 29, 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 Location
- SW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem · 1
A REVISION SURGERY REPORTEDLY OCCURRED IN 2006 INVOLVING AN X STOP IPD IMPLANT AT L4/L5. THE SURGERY NOTED AN IMPLANT DISLOCATION AND A SPINOUS PROCESS FRACTURE AT L4.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | X STOP IPD SYSTEM | INTERSPINOUS PROCESS PROSTHESIS | NQO | ST. FRANCIS MEDICAL TECHNOLOGIES, INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |