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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 791430
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
0 of 1 device's were returned for evaluation. We are awaiting the return of 1 device. 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 phoenix handpiece would not hold burs. No injury resulted in the event.
 
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Brand NameMIDWEST PHOENIX
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 Key12257082
MDR Text Key266379423
Report Number9614977-2021-00043
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
PMA/PMN Number
K131319
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Type of Report Initial
Report Date 07/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number791430
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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