FDA Adverse Event
Injury
Summary report: N
TRUMATCH
MDR report key: 18373693
·
Received December 21, 2023
Report
- Report Number
- 3005718816-2023-00004
- Event Type
- Injury
- Date Received
- December 21, 2023
- Date of Event
- October 5, 2023
- Report Date
- December 6, 2023
- Manufacturer
- MATERIALISE USA, LLC
- Product Code
- JEY
- UDI-DI
- 05420060380167
- PMA / PMN Number
- K170272
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE INVESTIGATION CONCLUDED THAT THE DEVICES MET SPECIFICATIONS AND DID NOT MALFUNCTION. THE EVENT IS ATTRIBUTED TO THE PATIENT'S ALLERGY.
Additional Manufacturer Narrative · 0
INVESTIGATION ONGOING.
Additional Manufacturer Narrative · 0
SECTION D4 - SERIAL NUMBER HAS BEEN DELETED AS IT IS NOT PRESENT IN THE LABEL - UDI RELATED DATA QUALITY UPDATES ONLY. SECTION G6 - TYPE OF REPORT CHANGED FROM "FOLLOW-UP #1" TO "FOLLOW-UP # 2".
Description of Event or Problem · 0
HARDWARE WAS REMOVED FROM THE PATIENT DUE TO HIS ALLERGY TO METAL.
Description of Event or Problem · 0
HARDWARE WAS REMOVED FROM THE PATIENT DUE TO HIS ALLERGY TO METAL.
Description of Event or Problem · 0
HARDWARE WAS REMOVED FROM THE PATIENT DUE TO HIS ALLERGY TO METAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 297126 | TRUMATCH | TRUMATCH MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MANDIBLE, MINI | JEY | MATERIALISE USA, LLC | SD980.016 | MU23OHOXIF | 05420060380167 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Male | Other |