FDA Adverse Event
Injury
Summary report: N
GORILLA PLATING SYSTEM
MDR report key: 14876503
·
Received June 30, 2022
Report
- Report Number
- 3008650117-2022-00069
- Event Type
- Injury
- Date Received
- June 30, 2022
- Date of Event
- June 2, 2022
- Report Date
- June 30, 2022
- Manufacturer
- PARAGON 28, INC
- Product Code
- HWC
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
REPORT 2 OF 2. (B)(4).
Description of Event or Problem · 0
PATIENT WAS INVOLVED IN MOTOR VEHICLE ACCIDENT; PLATES AND SCREWS WERE IMPLANTED. A SCREW BROKE PRIOR TO PLANNED ADDITIONAL SURGERY TO ADDRESS A BONE VOID.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2058997 | GORILLA PLATING SYSTEM | SCREW | HWC | PARAGON 28, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Male | Required Intervention |