FDA Adverse Event
Other
Summary report: N
X STOP IPD SYSTEM
MDR report key: 797631
·
Received November 30, 2006
Report
- Report Number
- 2953720-2006-00009
- Event Type
- Other
- Date Received
- November 30, 2006
- Date of Event
- October 17, 2006
- Report Date
- November 30, 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 Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
H.6.: METHOD: DEVICE NOT RETURNED. RESULTS: NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
IMPLANTATION OF TWO X STOP INTERSPINOUS DECOMPRESSION SYSTEM IMPLANTS WAS PLANNED AT THE L3-4 AND L4-5 LUMBAR LEVELS UNDER LOCAL ANESTHESIA IN A PATIENT WHO WAS REPORTEDLY VERY OSTEOPOROTIC. DURING THE PREPARATION PHASE OF THE PROCEDURE, THE L3 SPINOUS PROCESS WAS FRACTURED. THE PROCEDURE WAS ABORTED AND NO X STOP DEVICES WERE IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | X STOP IPD SYSTEM | INTERSPINOUS PRCESS PROSTHESIS | NQO | ST. FRANCIS MEDICAL TECHNOLOGIES, INC | NA | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Other |