• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SIRONA DENTAL SYSTEMS GMBH MIDWEST E PRO 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT HANDPIECE, AIR-POWERED, DENTAL Back to Search Results
Catalog Number 875105
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). 2 of 5 devices have been returned for evaluation. Evaluation of 1 device found chuck wear and lack of maintenance. The device was cleaned of debris and the turbine was replaced. The device was repaired and returned to the customer. Evaluation of 1 device found normal chuck wear and the turbine needed to be replaced. The device was repaired and returned to the customer.
 
Event Description
This report summarizes 5 malfunction events. This report summarizes 5 malfunction events where a midwest e pro handpiece would not hold dental burs. There were no injuries in any of the events.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMIDWEST E PRO 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
karl nittinger
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494424
MDR Report Key10767373
MDR Text Key214143669
Report Number9614977-2020-00037
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
PMA/PMN Number
K965238
Number of Events Reported5
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 Number875105
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

-
-