FDA Adverse Event
Other
Summary report: N
X STOP IPD SYSTEM
MDR report key: 755199
·
Received August 21, 2006
Report
- Report Number
- 2953720-2006-00005
- Event Type
- Other
- Date Received
- August 21, 2006
- Date of Event
- July 21, 2006
- Report Date
- August 18, 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
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD: DEVICE NOT RETURNED. RESULTS/CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. TWO DEVICES INVOLVED. SECOND DEVICE MFG DATE JUNE 2006. ADD'L CATALOG # 1-2210, ADD'L LOT # 060608.
Description of Event or Problem · 1
TWO X STOP INTERSPINOUS DECOMPRESSION SPINAL IMPLANTS WERE INSERTED AT L3-4 AND L4-5. THREE DAYS LATER, THE PATIENT RETURNED TO THE DOCTOR WITH MODERATE TO SEVERE PAIN. X-RAYS IDENTIFIED A FRACTURE OF THE SPINOUS PROCESS AT L4. BOTH X STOP IMPLANTS WERE SUBSEQUENTLY REMOVED AND A LAMINECTOMY WAS PERFORMED CONCURRENTLY.
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 | 060111 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |