FDA Adverse Event
Other
Summary report: N
X STOP IPD SYSTEM
MDR report key: 795139
·
Received November 28, 2006
Report
- Report Number
- 2953720-2006-00008
- Event Type
- Other
- Date Received
- November 28, 2006
- Report Date
- November 28, 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
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
H6: DEVICE NOT RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. DATE OF EVENT IS UNK.
Description of Event or Problem · 1
ONE X STOP INTERSPINOUS DECOMPRESSION SPINAL IMPLANT WAS INSERTED AT L4-L5 IN 2006. PATIENT COMPLAINED OF A RETURN OF STENOSIS SYMPTOMS AT THE 3 WEEKS POSTOPERATIVE VISIT AT WHICH TIME A SPINOUS PROCESS FRACTURE AT L5 WAS CONFIRMED BY X-RAY. IT WAS REPORTED THAT PATIENT HAS ELECTED TO UNDERGO FURTHER DECOMPRESSION SURGERY AT WHICH TIME THE IMPLANT WILL BE REMOVED.
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 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |