FDA Adverse Event
Other
Summary report: N
X STOPPK IPD SYSTEM
MDR report key: 799190
·
Received December 21, 2006
Report
- Report Number
- 2953720-2006-00015
- Event Type
- Other
- Date Received
- December 21, 2006
- Date of Event
- December 26, 2005
- Report Date
- December 21, 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
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
H6: METHOD: DEVICE NOT RETURNED. RESULTS AND CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
PATIENT REPORTEDLY EXPERIENCED A MINOR TRAUMA. SUBSEQUENT X-RAY CONFIRMED SPINOUS PROCESS FRACTURE AT L4. AT 3 MONTHS POST, PATIENT UNDERWENT REVISION SURGERY TO REMOVE IMPLANT IN 2005.
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. | 1-3010 | 050725 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |