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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MIDWEST E PLUS 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT HANDPIECE, AIR-POWERED, DENTAL

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SIRONA DENTAL SYSTEMS GMBH MIDWEST E PLUS 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT HANDPIECE, AIR-POWERED, DENTAL Back to Search Results
Catalog Number 875205
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 e plus handpiece would not hold burs. No injury resulted in the event.
 
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Brand NameMIDWEST E PLUS 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT
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 Key14251675
MDR Text Key290452840
Report Number9614977-2022-00029
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
PMA/PMN Number
K972436
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 04/29/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue Number875205
Was Device Available for Evaluation? No Answer Provided
Was Device Evaluated by Manufacturer? No Answer Provided

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