Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC ATR TECNIKA DIGITAL TORQUE CONTROL MOTOR; 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
 

TULSA DENTAL PRODUCTS LLC ATR TECNIKA DIGITAL TORQUE CONTROL MOTOR; HANDPIECE, AIR-POWERED, DENTAL Back to Search Results
Catalog Number ATRTECHMTR
Device Problems Mechanical Problem (1384); Failure to Shut Off (2939)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
There has been a previous report received where this malfunction has caused file separation.Since separation of a file could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
 
Event Description
In this event it was reported that a atr technika motor runs constantly when turned on.The event outcome is unknown as of this mdr evaluation.
 
Manufacturer Narrative
Multiple unsuccessful attempts were made to obtain the patient outcome.Multiple unsuccessful attempts were made to obtain the device for evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ATR TECNIKA DIGITAL TORQUE CONTROL MOTOR
Type of Device
HANDPIECE, AIR-POWERED, DENTAL
Manufacturer (Section D)
TULSA DENTAL PRODUCTS LLC
608 rolling hills drive
johnson city TN 37604
MDR Report Key9535660
MDR Text Key184459964
Report Number2320721-2019-00276
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
PMA/PMN Number
K000547
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 03/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberATRTECHMTR
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-