FDA Adverse Event
Injury
Summary report: N
TRUMATCH
MDR report key: 21323517
·
Received February 6, 2025
Report
- Report Number
- 3005718816-2025-00002
- Event Type
- Injury
- Date Received
- February 6, 2025
- Date of Event
- February 1, 2024
- Report Date
- January 7, 2025
- Manufacturer
- MATERIALISE USA, LLC
- Product Code
- JEY
- UDI-DI
- 05420060380211
- PMA / PMN Number
- K170272
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
INVESTIGATION CONCLUDED THAT DEVICES MET SPECIFICATIONS. IT IS CONCLUDED THAT BREAKAGE OF THE PLATE IS CAUSED BY USE OF THE PLATE WITHOUT A BONE GRAFT CAUSING EXCESSIVE AND PROLONGED STRESSES ON THE PLATE WHICH IS NOT INTENDED.
Description of Event or Problem · 0
THE PLATE WAS REPORTED BROKEN AND ADDITIONAL SURGICAL INTERVENTION IS PLANNED TO REMOVE THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1298724 | TRUMATCH | TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MANDIBLE, LARGE | JEY | MATERIALISE USA, LLC | SD980.021 | MU23AQOBIT | 05420060380211 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Male | Other |