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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 790044
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for evalauation.
 
Event Description
This report summarizes 1 malfunction event where a midwest tradition handpiece would not hold burs. No injury resulted.
 
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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
joleta ness
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494593
MDR Report Key11758360
MDR Text Key251736400
Report Number9614977-2021-00011
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,Followup
Report Date 06/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number790044
Device Lot Number1111BN3775
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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