FDA Adverse Event
Other
Summary report: N
X STOP IPD SYSTEM
MDR report key: 734879
·
Received July 13, 2006
Report
- Report Number
- 2953720-2006-00002
- Event Type
- Other
- Date Received
- July 13, 2006
- Date of Event
- June 19, 2006
- Report Date
- July 13, 2006
- Manufacturer
- ST. FRANCIS MEDICAL TECHNOLOGIES, INC.
- Product Code
- NQO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE COMPANY FOR EVALUATION AND INFORMATION ABOUT THIS EVENT IS LIMITED. NO CONCLUSION CAN BE MADE AT THIS TIME AND NO CONNECTION CAN BE MADE BETWEEN THE REPORTED EVENT AND ANY SHORTCOMING OF THE DEVICE. AS SURGICAL INTERVENTION OCCURRED, AN MDR IS BEING FILED TO DOCUMENT THIS EVENT.
Description of Event or Problem · 1
AN X STOP INTERSPINOUS DECOMPRESSION SPINAL IMPLANT WAS INSERTED AT THE L4-L5 LEVEL; THE PATIENT WAS REPORTED TO HAVE A "DIMINUTIVE" L5 SPINOUS PROCESS. NINE DAYS LATER, PATIENT EXPERIENCED PAIN. A SHIFT IN THE POSITION OF THE IMPLANT WAS NOTED ON X-RAYS. IN 2006, A PROCEDURE WAS PERFORMED TO REPLACE THE IMPLANT WITH A LARGER SIZE X STOP IMPLANT.
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. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |