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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WAVEONE GOLD PRIMARY 6-FILE STER 31MM; FILE, PULP CANAL, ENDODONTIC
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WAVEONE GOLD PRIMARY 6-FILE STER 31MM; FILE, PULP CANAL, ENDODONTIC Back to Search Results
Catalog Number A0756231G0P03
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 patient has been referred to an endodontist.The outcome of the event is unknown as of this mdr evaluation.
 
Manufacturer Narrative
Multiple unsuccessful attempts were made to obtain the patient outcome.Returned file is actually broken at the tip of the active part (fatigue).No material defect was found during analysis of the rupture pattern.No unused file is available for evaluation.The batch number is unknown, dhr cannot be reviewed.Root causes are not identified.We will track this kind of event and monitor the trend.
 
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Brand Name
WAVEONE GOLD PRIMARY 6-FILE STER 31MM
Type of Device
FILE, PULP CANAL, ENDODONTIC
MDR Report Key12671810
MDR Text Key280085437
Report Number8031010-2021-00237
Device Sequence Number1
Product Code EKS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 11/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberA0756231G0P03
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/07/2021
Date Manufacturer Received09/23/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
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