FDA Adverse Event
Injury
Summary report: N
PLATE, FIXATION, BONE
MDR report key: 3942122
·
Received July 17, 2014
Report
- Report Number
- 3025141-2014-00175
- Event Type
- Injury
- Date Received
- July 17, 2014
- Report Date
- June 20, 2014
- Manufacturer
- ACUMED LLC
- Product Code
- HRS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
APPROXIMATELY FIVE YEARS AFTER IMPLANTATION, THE PATIENT EXPERIENCED FPL RUPTURE FOLLOWING VOLAR PLATING OF THE WRIST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 418194 | PLATE, FIXATION, BONE | HRS | ACUMED LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |