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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MIDWEST E MINI 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT; HANDPIECE, AIR-POWERED, DENTAL
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SIRONA DENTAL SYSTEMS GMBH MIDWEST E MINI 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT; HANDPIECE, AIR-POWERED, DENTAL Back to Search Results
Catalog Number 875101
Device Problem Overheating of Device (1437)
Patient Problems Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Additional serial numbers included in this report: (b)(4).2 of 11 devices have been returned for evaluation.Evaluation of the two returned device found excessive wear due to a lack of proper maintenance.This devices did not heat up during evaluation.The devices were repaired and returned to the customers.
 
Event Description
This report summarizes 11 malfunction events.This report summarizes 11 malfunction events where a midwest e mini handpiece overheated.There were two events where patients received a minor burn, no intervention was required.There were 9 events with no injuries in any of the events.
 
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Brand Name
MIDWEST E MINI 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT
Type of Device
HANDPIECE, AIR-POWERED, DENTAL
Manufacturer (Section D)
SIRONA DENTAL SYSTEMS GMBH
fabrikstrasse 31
bensheim, hessen D-646 25
GM  D-64625
Manufacturer (Section G)
SIRONA DENTAL SYSTEMS GMBH
fabrikstrasse 31
bensheim, hessen D-646 25
GM   D-64625
Manufacturer Contact
karl nittinger
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494424
MDR Report Key10767387
MDR Text Key214144054
Report Number9614977-2020-00045
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
PMA/PMN Number
K972436
Number of Events Reported11
Summary Report (Y/N)Y
Report Source Manufacturer
Type of Report Initial
Report Date 10/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number875101
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/31/2020
Type of Device Usage N
Patient Sequence Number1
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