FDA Adverse Event
Injury
Summary report: N
PLASTIC CIRCULAR PLATE
MDR report key: 4080800
·
Received September 5, 2014
Report
- Report Number
- MW5038116
- Event Type
- Injury
- Date Received
- September 5, 2014
- Date of Event
- July 25, 2014
- Report Date
- September 5, 2014
- Manufacturer
- TRIMED, INC.
- Product Code
- HRS
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- VT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
PT BROUGHT TO OPERATING ROOM FOR SYMPTOMATIC LOOSE HARDWARE OF THE LEFT WRIST. STATUS POST INTERCARPAL FUSION. REMOVAL OF TRIMED CIRCULAR PLATE AND SCREWS FRACTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 543360 | PLASTIC CIRCULAR PLATE | CIRCULAR PLASTIC PLATE | HRS | TRIMED, INC. | C140701 | 811K |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |