• 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 TRADITION PRO HANDPIECE 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 TRADITION PRO HANDPIECE HANDPIECE, AIR-POWERED, DENTAL Back to Search Results
Catalog Number 780345
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
3 of 3 devices were returned for evaluation. Evaluation of 2 devices found normal chuck wear and the turbines needed to be replaced. The devices were repaired and returned to the customers. 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.
 
Event Description
This report summarizes 3 malfunction events where a midwest tradition pro handpiece would not hold burs. No injury resulted in any of the events.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMIDWEST TRADITION PRO HANDPIECE
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 Key14251669
MDR Text Key290452439
Report Number9614977-2022-00018
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
PMA/PMN Number
K131319
Number of Events Reported3
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 Number780345
Was Device Available for Evaluation? No Answer Provided
Was Device Evaluated by Manufacturer? No Answer Provided

-
-