FDA Adverse Event
Malfunction
Summary report: N
FIREBIRD (PHOENIX)
MDR report key: 2432555
·
Received January 20, 2012
Report
- Report Number
- 3008524126-2011-00042
- Event Type
- Malfunction
- Date Received
- January 20, 2012
- Date of Event
- December 8, 2011
- Report Date
- January 18, 2012
- Manufacturer
- ORTHOFIX INC.
- Product Code
- NKB
- PMA / PMN Number
- K081684
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE RETURNED ROD INSERTERS WERE EVALUATED. THE DISTAL END OF THE INSERTERS WERE FRACTURED AND THE HEX TIPS WERE NOT RETURNED FOR EVAL. EXCESSIVE FORCE APPLIED TO THE INSTRUMENT ULTIMATELY RESULTED IN THE INSTRUMENT FAILURES. PROCESS STEPS THAT AFFECT THE SURFACE FINISH WHERE THE CRACKS INITIATED MAY ALSO CONTRIBUTE TO THE FAILURES.
Description of Event or Problem · 1
BASED ON INFO PROVIDED THE ROD HOLDER/INSERTER INSTRUMENT BROKE DURING SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FIREBIRD (PHOENIX) | ROD HOLDER/INSERTER | NKB | ORTHOFIX INC. | 20-0214 (X2) | 32586-NC07 (X2) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Other |