FDA Adverse Event
Other
Summary report: N
X STOP IPD SYSTEM
MDR report key: 799901
·
Received December 14, 2006
Report
- Report Number
- 2953720-2006-00010
- Event Type
- Other
- Date Received
- December 14, 2006
- Date of Event
- October 30, 2006
- Report Date
- December 14, 2006
- Manufacturer
- ST. FRANCIS MED DEVICE 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
DURING PLACEMENT OF THE X STOP INTERSPINOUS DECOMPRESSION SPINAL IMPLANT, SURGEON HAD DIFFICULTY REMOVING THE SCREWDRIVER. AS THE SCREWDRIVER WAS REMOVED, THE SUPRASPINOUS LIGAMENT WAS TORN. THE IMPLANT WAS SECURED IN PLACE WITH SUTURES ALONG THE LIGAMENT. PROCEDURE WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | X STOP IPD SYSTEM | INTERSPINOUS PROCESS PROSTHESIS | NQO | ST. FRANCIS MED DEVICE TECHNOLOGIES, INC. | NA | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |