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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MIDWEST TRADITION HANDPIECE HANDPIECE, AIR-POWERED, DENTAL

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SIRONA DENTAL SYSTEMS GMBH MIDWEST TRADITION HANDPIECE HANDPIECE, AIR-POWERED, DENTAL Back to Search Results
Catalog Number 780044
Device Problem Fitting Problem (2183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The device is available for evaluation, though has not been returned as of this report. Evaluation results will be submitted as they become available.
 
Event Description
This report summarizes 1 malfunction events. This report summarizes one malfunction event where a midwest tradition handpiece would not hold dental burs. There were no injuries in any of the events.
 
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Brand NameMIDWEST TRADITION HANDPIECE
Type of DeviceHANDPIECE, 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 Key10767363
MDR Text Key220250486
Report Number9614977-2020-00024
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
PMA/PMN Number
K131319
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Type of Report Initial
Report Date 10/31/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number780044
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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