MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-11-29 for ELEMENT RC INICELL, PF 4.5, E 4.2, L9.5 4.23.133 manufactured by Thommen Medical Ag.
| Report Number | 3003184527-2019-01557 |
| MDR Report Key | 9391626 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-11-29 |
| Date of Report | 2019-11-29 |
| Date of Event | 2019-11-12 |
| Date Mfgr Received | 2019-11-29 |
| Device Manufacturer Date | 2019-06-27 |
| Date Added to Maude | 2019-11-29 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. ASTRID WEBER |
| Manufacturer Street | NECKARSULMSTRASSE 28 |
| Manufacturer City | GRENCHEN 2540 |
| Manufacturer Country | CH |
| Manufacturer Postal | 2540 |
| Manufacturer G1 | THOMMEN MEDICAL AG |
| Manufacturer Street | NECKARSULMSTRASSE 28 |
| Manufacturer City | GRENCHEN 2540 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 2540 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELEMENT RC INICELL, PF 4.5, E 4.2, L9.5 |
| Generic Name | DENTAL IMPLANT |
| Product Code | DZE |
| Date Received | 2019-11-29 |
| Model Number | 4.23.133 |
| Lot Number | 20379 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THOMMEN MEDICAL AG |
| Manufacturer Address | NECKARSULMSTRASSE 28 GRENCHEN 2540 CH 2540 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-29 |