FDA Adverse Event
Malfunction
Summary report: N
FIREBIRD SPINAL FIXATION SYSTEM
MDR report key: 3063193
·
Received February 27, 2013
Report
- Report Number
- 3008524126-2013-00003
- Event Type
- Malfunction
- Date Received
- February 27, 2013
- Date of Event
- January 9, 2013
- Report Date
- February 27, 2013
- Manufacturer
- ORTHOFIX, INC.
- Product Code
- NKB
- PMA / PMN Number
- K092624
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
BASED ON THE INFO PROVIDED, THE 52-2450 RODS WERE BROKEN IN TWO PLACES, ONE EACH SIDE OF THE CONSTRUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 84401 | FIREBIRD SPINAL FIXATION SYSTEM | ROD, 450MMX5.5MM COBALT CHROME | NKB | ORTHOFIX, INC. | 51-2450 (X2) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Other |