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U.S. Department of Health and Human Services

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

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SIRONA DENTAL SYSTEMS GMBH MIDWEST PHOENIX HANDPIECE, AIR-POWERED, DENTAL Back to Search Results
Catalog Number 793400
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
4 of 4 devices were returned for evaluation. Evaluation of 4 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 4 malfunction events where midwest phoenix handpieces would not hold burs. No injury resulted in any of the events.
 
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Brand NameMIDWEST PHOENIX
Type of DeviceHANDPIECE, 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 Key11256684
MDR Text Key229595480
Report Number9614977-2020-00062
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 01/31/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number793400
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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