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 WAVEONE GOLD RECIPROCATING FILE SMALL 21MM; FILE, PULP CANAL, ENDODONTIC
  • 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 WAVEONE GOLD RECIPROCATING FILE SMALL 21MM; FILE, PULP CANAL, ENDODONTIC Back to Search Results
Catalog Number WGSMALL21
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  malfunction  
Event Description
It was reported that 2 waveone gold reciprocating files separated in the canal.Instrument was incorporated as part of the fill.This report is for the 2nd device - 2 of 2.
 
Manufacturer Narrative
As a result of this malfunction, the potential for surgical intervention exists to preclude permanent damage to a body structure or permanent impairment of a body function as evidenced by previous reported events with similar files.This event, therefore, is reportable per 21cfr part 803.This report is for the 2nd device - 2 of 2 device not returned and no inventory on hand to inspect.Nothing unusual to report was found during dhr review.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
WAVEONE GOLD RECIPROCATING FILE SMALL 21MM
Type of Device
FILE, PULP CANAL, ENDODONTIC
Manufacturer (Section D)
TULSA DENTAL PRODUCTS LLC
608 rolling hills drive
johnson city TN 37604
Manufacturer (Section G)
TULSA DENTAL PRODUCTS LLC
608 rolling hills drive
johnson city TN 37604
Manufacturer Contact
hannah seevaratnam
221 w. philadelphia st.
york, PA 17401
7178494593
MDR Report Key12778467
MDR Text Key280516111
Report Number2320721-2021-00089
Device Sequence Number1
Product Code EKS
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 11/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberWGSMALL21
Device Lot Number0000269166
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/14/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Patient Sequence Number1
-
-