FDA Adverse Event
Malfunction
Summary report: N
CLAMP, MULTIPLANAR, LRS
MDR report key: 525137
·
Received February 13, 2004
Report
- Report Number
- 9680825-2004-00001
- Event Type
- Malfunction
- Date Received
- February 13, 2004
- Report Date
- February 13, 2004
- Manufacturer
- ORTHOFIX SRL
- Product Code
- JEC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A LRS MUTIPLANAR CLAMP WAS APPLIED TO CORRECT AN ANGULAR DEFORMITY OF THE PATIENT'S PROXIMAL TIBIA. AFTER APPLICATION AND INTO THE TREATMENT PERIOD, THE SMALL COMPRESSION/DISTRACTION UNIT LOCKED INTO POSITION, AND THE CORRECTION COULD NOT BE COMPLETED. WHEN THE PHYSICIAN APPLIED GREATER FORCE TO EFFECT CORRECTION THE DEVICE BROKE. THE CLAMP WAS REPLACED WITH A NEW ONE, AS THE SMALL DISTRACTOR BREAKAGE COULD AFFECT THE FIXATOR STABILITY. THE PATIENT IS EXPECTED TO HEAL AS DESIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLAMP, MULTIPLANAR, LRS | EXTERNAL FIXATION | JEC | ORTHOFIX SRL | 50580 | B21 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR |