FDA Adverse Event
Death
Summary report: N
THORP PLATE
MDR report key: 287477
·
Received July 31, 2000
Report
- Report Number
- 2520274-2000-00040
- Event Type
- Death
- Date Received
- July 31, 2000
- Date of Event
- April 16, 1999
- Report Date
- June 29, 2000
- Manufacturer
- SYNTHES USA
- Product Code
- HRS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT WAS IMPLANTED WITH THE THORP PLATE IN 1996. THE PLATE WAS NOTED BROKEN IN 1999. THE PLATE WAS REMOVED ON AN UNKNOWN DATE.
Description of Event or Problem · 1
THE PLATE WAS REMOVED ON 6/17/99.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THORP PLATE | RECONSTRUCTION PLATE | HRS | SYNTHES USA | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention | UNKNOWN SCREWS (1996 TO NI). |