FDA Adverse Event
Malfunction
Summary report: N
PMF, THREADED WIRES D 2.0 MM LENGTH 100/15 MM
MDR report key: 1250792
·
Received December 2, 2008
Report
- Report Number
- 2183449-2008-00013
- Event Type
- Malfunction
- Date Received
- December 2, 2008
- Report Date
- December 2, 2008
- Manufacturer
- ORTHOFIX SRL
- Product Code
- LRN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IN 2008, AT THE HOSPITAL, A MINI FIXATOR WAS APPLIED FOR A CALLUS DISTRACTION PROCEDURE. A REVISION SURGERY WAS NEEDED A FEW WEEKS LATER BECAUSE 2 OF THE 4 IMPLANTED PINS BROKE, AS THE PATIENT WAS DISTRACTING WITH THE FIXATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PMF, THREADED WIRES D 2.0 MM LENGTH 100/15 MM | THREADED WIRES D 2.0 MM LENGTH 100/15MM | LRN | ORTHOFIX SRL | M426 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |