FDA Adverse Event
Other
Summary report: N
X STOP IPD SYSTEM
MDR report key: 751330
·
Received August 10, 2006
Report
- Report Number
- 2953720-2006-00004
- Event Type
- Other
- Date Received
- August 10, 2006
- Date of Event
- August 1, 2006
- Report Date
- August 10, 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
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
METHOD: DEVICE NOT RETURNED. RESULTS: NO CONCLUSION CAN BE DRAWN AT THIS TIME. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
PT REPORTED THAT AN X STOP INTERSPINOUS DECOMPRESSION SPINAL IMPLANT WAS INSERTED IN 2006 AT L4-5. A FEW DAYS AFTER THE PROCEDURE, PT EXPERIENCED DISCOMFORT. TWO WEEKS AFTER SURGERY, REPORTEDLY, A DEVICE DISLODGEMENT WAS NOTED ON X-RAY. DATE OF DISLODGEMENT IS UNKNOWN. PT CONCURRENTLY UNDERWENT LAMINECTOMY SURGERY AT THE TIME OF DEVICE REMOVAL.
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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |