ELEMENT RC INICELL, PF 4.5, E 4.2, L9.5 4.23.133

MAUDE Adverse Event Report

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.

MAUDE Entry Details

Report Number3003184527-2019-01557
MDR Report Key9391626
Report SourceHEALTH PROFESSIONAL
Date Received2019-11-29
Date of Report2019-11-29
Date of Event2019-11-12
Date Mfgr Received2019-11-29
Device Manufacturer Date2019-06-27
Date Added to Maude2019-11-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. ASTRID WEBER
Manufacturer StreetNECKARSULMSTRASSE 28
Manufacturer CityGRENCHEN 2540
Manufacturer CountryCH
Manufacturer Postal2540
Manufacturer G1THOMMEN MEDICAL AG
Manufacturer StreetNECKARSULMSTRASSE 28
Manufacturer CityGRENCHEN 2540
Manufacturer CountryCH
Manufacturer Postal Code2540
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameELEMENT RC INICELL, PF 4.5, E 4.2, L9.5
Generic NameDENTAL IMPLANT
Product CodeDZE
Date Received2019-11-29
Model Number4.23.133
Lot Number20379
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerTHOMMEN MEDICAL AG
Manufacturer AddressNECKARSULMSTRASSE 28 GRENCHEN 2540 CH 2540


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-11-29

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