FDA Adverse Event
Injury
Summary report: N
TRUMATCH
MDR report key: 21125421
·
Received January 10, 2025
Report
- Report Number
- 3005718816-2025-00001
- Event Type
- Injury
- Date Received
- January 10, 2025
- Date of Event
- July 24, 2024
- Report Date
- December 11, 2024
- Manufacturer
- MATERIALISE USA, LLC
- Product Code
- JEY
- UDI-DI
- 05420060380013
- PMA / PMN Number
- K170272
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative · 0
THE INVESTIGATION CONCLUDED THAT THE DEVICE MET THE SPECIFICATIONS. INVESTIGATION SHOWED THAT THE PATIENT HAS SPECIFIC MANDIBLE ANATOMY WHICH COULD COMPLICATE THE HEALING PROCESS. ADDITIONAL INFORMATION WAS REQUESTED TO UNDERSTAND THE REASONS FOR THE NONUNION OF BONES, BUT NOT OBTAINED AFTER SEVERAL ATTEMPTS. THUS, THE EXACT ROOT CAUSE REMAINED UNKNOWN.
Description of Event or Problem · 0
THE SURGEON HAS REPORTED THAT MANDIBLE HARDWARE IS BEING REMOVED DUE TO POST-OP COMPLICATIONS.
Description of Event or Problem · 0
THE SURGEON HAS REPORTED THAT MANDIBLE HARDWARE IS BEING REMOVED DUE TO POST-OP COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 517592 | TRUMATCH | TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MANDIBLE, MINI | JEY | MATERIALISE USA, LLC | SD980.016 | MU24TUZBOP | 05420060380013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Female | Other |