FDA Adverse Event
Malfunction
Summary report: N
FIREBIRD SPINAL FIXATION SYSTEM
MDR report key: 2771412
·
Received September 27, 2012
Report
- Report Number
- 3008524126-2012-00025
- Event Type
- Malfunction
- Date Received
- September 27, 2012
- Date of Event
- August 27, 2012
- Report Date
- September 28, 2012
- Manufacturer
- ORTHOFIX, INC.
- Product Code
- NKB
- PMA / PMN Number
- K081684
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
BASED ON THE INFO PROVIDED, TWO OF THE PRONGS BROKE OFF ON THE DISTAL END OF THE MODULAR SCREW DRIVER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FIREBIRD SPINAL FIXATION SYSTEM | MODULAR SCREW DRIVER | NKB | ORTHOFIX, INC. | 52-1832 | 36494-OE25 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other |