MIDWEST E MINI 1:5 HIGHSPEED ATTACHMENT 875101

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 2019-05-24 for MIDWEST E MINI 1:5 HIGHSPEED ATTACHMENT 875101 manufactured by Sirona Dental Systems Gmbh.

Event Text Entries

[146107286] Handpiece got hot. Handpiece failed specs due to complete bur bearing failure on turbine. Replaced head drive. Replaced water hoses and water valve.
Patient Sequence No: 1, Text Type: N, H10


[146107287] It was reported that a midwest e mini 1:5 ca overheated; no injury resulted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9614977-2019-00082
MDR Report Key8641760
Report SourceHEALTH PROFESSIONAL
Date Received2019-05-24
Date of Report2019-05-24
Date Mfgr Received2019-04-25
Date Added to Maude2019-05-24
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 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 E MINI 1:5 HIGHSPEED ATTACHMENT
Generic NameHANDPIECE, BELT AND/OR GEAR DRIVEN, DENTAL
Product CodeEFA
Date Received2019-05-24
Returned To Mfg2019-05-02
Model NumberNA
Catalog Number875101
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSIRONA DENTAL SYSTEMS GMBH
Manufacturer AddressFABRIKSTRASSE 31 BENSHEIM, D-64625 GM D-64625


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-24

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