FDA Adverse Event
Malfunction
Summary report: N
TRUELOK RING FIXATION SYSTEM
MDR report key: 2435828
·
Received January 26, 2012
Report
- Report Number
- 3008524126-2011-00047
- Event Type
- Malfunction
- Date Received
- January 26, 2012
- Date of Event
- December 28, 2011
- Report Date
- January 26, 2012
- Manufacturer
- ORTHOFIX INC.
- Product Code
- LXT
- PMA / PMN Number
- K941048
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
INFO PROVIDED STATES THAT TWO (2) OLIVE WIRES ON THE TRUELOK FRAME BROKE AFTER PT BECAME WEIGHT BEARING AND WERE REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRUELOK RING FIXATION SYSTEM | TRUELOK BAYONET WIRE W/STOPPER | LXT | ORTHOFIX INC. | 54-1215 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Other |