FDA Adverse Event
Other
Summary report: N
X STOP IPD SYSTEM
MDR report key: 795044
·
Received November 27, 2006
Report
- Report Number
- 2953720-2006-00007
- Event Type
- Other
- Date Received
- November 27, 2006
- Date of Event
- October 25, 2006
- Report Date
- November 27, 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
- NURSE
Narratives
Additional Manufacturer Narrative · 1
H6: DEVICE NOT RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
ONE 12MM X STOP INTERSPINOUS DECOMPRESSION SPINAL IMPLANT WAS INSERTED AT L4-L5 WHILE THE PATIENT WAS REPORTEDLY IN A PRONE POSITION. IT WAS REPORTED THAT THE SURGEON EXPERIENCED DIFFICULTY PLACING IMPLANT DUE TO SPINAL ANATOMY. A SPINOUS PROCESS FRACTURE OCCURRED AT THE CEPHALED CURVE OF L5. SURGEON PUT PATIENT IN BRACE TO LIMIT MOVEMENT FOR TWO WEEKS FOLLOWING SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | X STOP IPD SYSTEM | INTERSPINOUS PROCESS PROTHESIS | NQO | ST. FRANCIS MEDICAL TECHNOLOGIES, INC. | NA | 060919 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |