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U.S. Department of Health and Human Services

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

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SIRONA DENTAL SYSTEMS GMBH MIDWEST STYLUS ATC; HANDPIECE, AIR-POWERED, DENTAL Back to Search Results
Catalog Number 884310
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
3 of 3 devices were returned for evaluation.Evaluation of 3 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 3 malfunction events where midwest stylus atc handpieces would not hold burs.No injury resulted in any of the events.
 
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Brand Name
MIDWEST STYLUS ATC
Type of Device
HANDPIECE, AIR-POWERED, DENTAL
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 Key11256690
MDR Text Key229602688
Report Number9614977-2020-00068
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
PMA/PMN Number
K003518
Number of Events Reported3
Summary Report (Y/N)Y
Report Source Manufacturer
Type of Report Initial
Report Date 01/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue Number884310
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/31/2021
Type of Device Usage N
Patient Sequence Number1
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