FDA Adverse Event
Injury
Summary report: N
TRANSFX EXTERNAL FIXATION SYSTEM MULTI-PIN CLAMP
MDR report key: 1001922
·
Received February 21, 2008
Report
- Report Number
- 1822565-2008-00061
- Event Type
- Injury
- Date Received
- February 21, 2008
- Date of Event
- January 14, 2008
- Report Date
- January 17, 2008
- Manufacturer
- ZIMMER, INC.
- Product Code
- LXT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT IS REPORTED THAT DURING POST-OP EVAL IN 2008, THE MULTI-PIN CLAMPS WERE FOUND TO BE LOOSE WHERE THEY WERE ATTACHED TO THE PINS IN TIBIA. UPON TIGHTENING THE SCREWS DOWN ONTO PIN FOR ALL THE CLAMPS, ONE BROKE AND REQUIRED SURGERY TO CHANGE THE CLAMP. SURGERY WAS PERFORMED ON TWO DAYS LATER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRANSFX EXTERNAL FIXATION SYSTEM MULTI-PIN CLAMP | EXTERNAL FIXATION CLAMP | LXT | ZIMMER, INC. | NA | 60776592 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK YR | Hospitalization| R |