• 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 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 HANDPIECE HANDPIECE, AIR-POWERED, DENTAL Back to Search Results
Catalog Number 780344
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 numbers included in this report: (b)(4). 7 of 8 devices were returned for evaluation. We are awaiting the return of 1 device. Evaluation of 5 devices found normal chuck wear and the turbines needed to be replaced. The devices were repaired and returned to the customers. Evaluation of 2 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 8 malfunction events where a midwest tradition 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 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 Key14251673
MDR Text Key290452850
Report Number9614977-2022-00017
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
PMA/PMN Number
K131319
Number of Events Reported8
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 Number780344
Was Device Available for Evaluation? No Answer Provided
Was Device Evaluated by Manufacturer? No Answer Provided

-
-