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 |