FDA Adverse Event
Malfunction
Summary report: N
5.5MM X 3.5MM VBS PEDICLE SCREW
MDR report key: 2505033
·
Received March 1, 2012
Report
- Report Number
- 3006088942-2012-00001
- Event Type
- Malfunction
- Date Received
- March 1, 2012
- Date of Event
- February 1, 2012
- Report Date
- February 29, 2012
- Manufacturer
- RELIANCE MEDICAL SYSTEMS
- Product Code
- MQP
- PMA / PMN Number
- K081383
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PT HAD INITIAL SURGERY (B)(6) 2010 AND RECEIVED THE SPINAL IMPLANT WITH PEDICLE SCREWS. SUBSEQUENTLY, AT AN UNK DATE, PT TOOK A FALL. PT REPORTED THEY HAD RECENTLY GONE TO A PAIN MGMT DR AND HE HAD X-RAYS TAKEN THAT SHOWED THE TWO BROKEN SCREWS. PT RETURNED TO THE ORIGINAL SURGEON WHO PERFORMED A REVISION OF THE HARDWARE (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 5.5MM X 3.5MM VBS PEDICLE SCREW | PEDICLE SCREW | MQP | RELIANCE MEDICAL SYSTEMS | 6-55-035 | 520195 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |