MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-14 for TRUMATCH SD980.001 manufactured by Materialise Nv.
[179420971]
A review of the internal documentation did not show an anomaly or deviation. A cause for this specific clinical event cannot be ascertained from the information provided. Should additional information become available and/or the device be returned for evaluation and an investigation result be available that changes this assessment, an amended medical device report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[179420972]
Revision surgery needed because screws backing out of the plate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003998208-2020-00001 |
| MDR Report Key | 9710934 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-14 |
| Date of Report | 2020-01-17 |
| Date of Event | 2019-11-27 |
| Date Mfgr Received | 2020-01-17 |
| Device Manufacturer Date | 2019-11-19 |
| Date Added to Maude | 2020-02-14 |
| 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, 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 | TRUMATCH ORTHOGNATHIC - FULL BIMAXILLARY SURGICAL KIT |
| Product Code | JEY |
| Date Received | 2020-02-14 |
| Model Number | SD980.001 |
| Catalog Number | SD980.001 |
| Lot Number | ME19ECIFIH |
| 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, VLAAMS-BRABANT 3001 BE 3001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-14 |