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U.S. Department of Health and Human Services

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

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SIRONA DENTAL SYSTEMS GMBH MIDWEST STYLUS HANDPIECE, AIR-POWERED, DENTAL Back to Search Results
Catalog Number 792300
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Additional serial number included in this report: (b)(4). 3 of 4 devices were returned for evaluation. Evaluation of 3 devices found chuck wear and lack of maintenance. The devices were cleaned of debris and the turbine was replaced. The devices were repaired and returned to the customer.
 
Event Description
This report summarizes 4 malfunction events. This report summarizes 4 malfunction events where a midwest stylus handpiece would not hold dental burs. There were no injuries in any of the events.
 
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Brand NameMIDWEST STYLUS
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 Key10767380
MDR Text Key214143459
Report Number9614977-2020-00034
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
PMA/PMN Number
K131319
Number of Events Reported4
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 Number792300
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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