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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY MAILLEFER WAVEONE GOLD ASSORT 4-FILE STER 25MM; FILE, PULP CANAL, ENDODONTIC

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DENTSPLY MAILLEFER WAVEONE GOLD ASSORT 4-FILE STER 25MM; FILE, PULP CANAL, ENDODONTIC Back to Search Results
Catalog Number A0754225G9A03
Device Problem Break (1069)
Patient Problems Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)
Event Type  malfunction  
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.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.
 
Event Description
In this event it was reported that a waveone gold file broke during use.The separated piece could be retrieved.Further information about potential patient's injury pending.
 
Manufacturer Narrative
Several assorted waveone gold instruments have been returned.Two waveone gold primary are in loose, the 8 other files are unused (2x w1gs, 2x w1gp, 3x w1gm and 1x w1gl).The files in loose have been analyzed.One file is actually broken at the base of the active part (fatigue).No material defect was found during analysis of the rupture pattern.Second file has no damage and seems unused.The two unused w1gp 25mm have been evaluated and were found in compliance with specifications.Nothing unusual to report was found during dhr review (batch #1660625).Multiple unsuccessful attempts were made to obtain the patient outcome.
 
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Brand Name
WAVEONE GOLD ASSORT 4-FILE STER 25MM
Type of Device
FILE, PULP CANAL, ENDODONTIC
Manufacturer (Section D)
DENTSPLY MAILLEFER
chemin du verger 3
ballaigues, 1338
SZ  1338
Manufacturer (Section G)
DENTSPLY MAILLEFER
chemin du verger 3
ballaigues, 1338
SZ   1338
Manufacturer Contact
hannah seevaratnam
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494593
MDR Report Key12640365
MDR Text Key279067363
Report Number8031010-2021-00232
Device Sequence Number1
Product Code EKS
Combination Product (y/n)N
Reporter Country CodeSW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Dentist
Type of Report Initial,Followup
Report Date 11/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberA0754225G9A03
Device Lot Number1660625
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/21/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/15/2021
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/16/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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