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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MIDWEST STYLUS ATC MINI HANDPIECE, AIR-POWERED, DENTAL

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SIRONA DENTAL SYSTEMS GMBH MIDWEST STYLUS ATC MINI HANDPIECE, AIR-POWERED, DENTAL Back to Search Results
Catalog Number 881300
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
2 of 2 devices were returned for evaluation. Evaluation of 2 devices found chuck wear and lack of maintenance. The devices were cleaned of debris and the turbines were replaced. The devices were repaired and returned to the customers.
 
Event Description
This report summarizes 2 malfunction events where a midwest stylus atc mini handpiece would not hold burs. No injury resulted.
 
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Brand NameMIDWEST STYLUS ATC MINI
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 Key11758380
MDR Text Key251755188
Report Number9614977-2021-00026
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
PMA/PMN Number
K972436
Number of Events Reported2
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 Number881300
Device Lot Number3685, 20179717
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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