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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
1 of 1 device was returned for evaluation. Evaluation of 1 device found normal chuck wear and the turbine needed to be replaced. The device was repaired and returned to the customer. This event is being submitted as part of vmsr. Only one event was received for this device during this quarter.
 
Event Description
This report summarizes 1 malfunction event where a midwest stylus handpiece would not hold burs. No injury resulted.
 
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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
hannah seevaratnam
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494593
MDR Report Key12725510
MDR Text Key279288328
Report Number9614977-2021-00069
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
PMA/PMN Number
K003518
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Type of Report Initial
Report Date 10/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/30/2021
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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