FDA Adverse Event
Malfunction
Summary report: N
ULTOS GENERAL FUSION T PLATE 6 HOLE
MDR report key: 17244165
·
Received July 1, 2023
Report
- Report Number
- 3008951116-2023-00002
- Event Type
- Malfunction
- Date Received
- July 1, 2023
- Date of Event
- April 4, 2021
- Report Date
- June 7, 2023
- Manufacturer
- ORTHO SOLUTIONS UK LTD
- Product Code
- HRS
- UDI-DI
- 05055662946512
- PMA / PMN Number
- K141784
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
IT WAS REPORTED TO ORTHO SOLUTIONS DIRECTLY FROM THE PATIENT THAT AN X-RAY CONFIRMED A POST-OPERATIVE PLATE FRACTURE 7 WEEKS AFTER INITIAL SURGERY. SUBSEQUENT REVISION SURGERY WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1207771 | ULTOS GENERAL FUSION T PLATE 6 HOLE | Plate, fixation, bone | HRS | ORTHO SOLUTIONS UK LTD | OS422716-NS | 2018001280/2018003122/41916B15 | 05055662946512 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |