FDA Adverse Event
Other
Summary report: N
X STOP IPD SYSTEM
MDR report key: 813670
·
Received February 2, 2007
Report
- Report Number
- 2953720-2007-00001
- Event Type
- Other
- Date Received
- February 2, 2007
- Date of Event
- January 5, 2007
- Report Date
- January 10, 2007
- 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. UNABLE TO OBTAIN ADDITIONAL INFORMATION FROM FACILITY. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
PATIENT UNDERWENT SURGICAL PROCEDURE IN 2007, AT WHICH TIME X STOP IMPLANTS WERE INSERTED AT TWO LEVELS; L4-5, AND L3-4. DURING THE PROCEDURE, A SPINOUS PROCESS FRACTURE OCCURRED AT L3-4; THE SURGEON ELECTED TO REMOVE BOTH IMPLANTS FOR LACK OF STABILITY, AND COMPLETED THE PROCEDURE BY PERFORMING A LAMINECTOMY DECOMPRESSION AT BOTH LEVELS.
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 |