MIDWEST TRADITION PLUS FIXED BACK END 770044

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-31 for MIDWEST TRADITION PLUS FIXED BACK END 770044 manufactured by Sirona Dental Systems Gmbh.

MAUDE Entry Details

Report Number9614977-2019-00132
MDR Report Key9262990
Date Received2019-10-31
Date of Report2019-10-31
Date Added to Maude2019-10-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Manufacturer ContactMR. KARL NITTINGER
Manufacturer Street221 W. PHILADELPHIA ST. SUITE 60W
Manufacturer CityYORK PA 17401
Manufacturer CountryUS
Manufacturer Postal17401
Manufacturer Phone7178494424
Manufacturer G1SIRONA DENTAL SYSTEMS GMBH
Manufacturer StreetFABRIKSTRASSE 31
Manufacturer CityBENSHEIM, D-64625
Manufacturer CountryGM
Manufacturer Postal CodeD-64625
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMIDWEST TRADITION PLUS FIXED BACK END
Generic NameHANDPIECE, AIR-POWERED, DENTAL
Product CodeEFB
Date Received2019-10-31
Model NumberNA
Catalog Number770044
Lot NumberNA
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSIRONA DENTAL SYSTEMS GMBH
Manufacturer AddressFABRIKSTRASSE 31 BENSHEIM, D-64625 GM D-64625


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-31

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