MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-19 for TRUMATCH SD980.016 manufactured by Materialise Nv.
| Report Number | 3003998208-2020-00002 |
| MDR Report Key | 9725662 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-19 |
| Date of Report | 2020-01-27 |
| Date of Event | 2019-12-02 |
| Date Mfgr Received | 2020-01-28 |
| Device Manufacturer Date | 2019-11-08 |
| Date Added to Maude | 2020-02-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JENNY JONES |
| Manufacturer Street | TECHNOLOGIELAAN 15 |
| Manufacturer City | LEUVEN, VLAAMS-BRABANT 3001 |
| Manufacturer Country | BE |
| Manufacturer Postal | 3001 |
| Manufacturer G1 | MATERIALISE NV |
| Manufacturer Street | TECHNOLOGIELAAN 15 |
| Manufacturer City | LEUVEN, VLAAMS-BRABANT 3001 |
| Manufacturer Country | BE |
| Manufacturer Postal Code | 3001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRUMATCH |
| Generic Name | MIDFACE/MANDIBLE - TITANIUM 3D PRINTED PLATE FOR MANDIBLE, MINI |
| Product Code | JEY |
| Date Received | 2020-02-19 |
| Model Number | SD980.016 |
| Catalog Number | SD980.016 |
| Lot Number | MU19LALSUS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MATERIALISE NV |
| Manufacturer Address | TECHNOLOGIELAAN 15 LEUVEN, 3001 BE 3001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-19 |