FDA Adverse Event
Malfunction
Summary report: N
9 HOLE VL GRIDLOCK FIBULA PLATE
MDR report key: 6529655
·
Received April 28, 2017
Report
- Report Number
- 3007420745-2017-00004
- Event Type
- Malfunction
- Date Received
- April 28, 2017
- Date of Event
- February 14, 2017
- Report Date
- April 28, 2017
- Manufacturer
- TRILLIANT SURGICAL, LTD
- Product Code
- HRS
- UDI-DI
- 00812926025445
- PMA / PMN Number
- K160177
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
THE ANKLE FRACTURE PLATE WAS IMPLANTED WITHIN THE LAST 4 MONTHS, ACCORDING TO THE SALES REPRESENTATIVE. THE PATIENT FELL 3 TIMES WITH THE PLATE AND CAME BACK TO THE ER AFTER THE LAST FALL, WHICH LED TO AN X-RAY THAT SHOWED THE BROKEN PLATE. THE DOCTOR REMOVED AND REPLACED THE PLATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313394 | 9 HOLE VL GRIDLOCK FIBULA PLATE | PLATE, FIXATION, BONE | HRS | TRILLIANT SURGICAL, LTD | TSL002873 | 00812926025445 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |