FDA Adverse Event
Malfunction
Summary report: N
4-HOLE STRAIGHT PLATE GRIDLOCK PLATING SYSTEM
MDR report key: 6895419
·
Received September 26, 2017
Report
- Report Number
- 3007420745-2017-00013
- Event Type
- Malfunction
- Date Received
- September 26, 2017
- Date of Event
- August 25, 2017
- Report Date
- September 26, 2017
- Manufacturer
- TRILLIANT SURGICAL, LTD
- Product Code
- HRS
- UDI-DI
- 00812926025407
- PMA / PMN Number
- K130964
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PLATE WAS IMPLANTED IN (B)(6) 2016. PATIENT REPORTED PAIN, X-RAY REVEALED THE PLATE WAS BROKEN. SURGEON NOTED THAT THERE WAS NO UNION, ONLY FIBROUS UNION. REVISION WAS PERFORMED ON (B)(6) 2017. SURGEON REPORTED THAT THE PATIENT WAS NON-COMPLIANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 675786 | 4-HOLE STRAIGHT PLATE GRIDLOCK PLATING SYSTEM | BONE PLATE, PRODUCT CODE: HRS | HRS | TRILLIANT SURGICAL, LTD | 00812926025407 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |