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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY MAILLEFER PROTAPER GOLD S1 25MM STER; FILE, PULP CANAL, ENDODONTIC
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DENTSPLY MAILLEFER PROTAPER GOLD S1 25MM STER; FILE, PULP CANAL, ENDODONTIC Back to Search Results
Catalog Number A0410225G0103
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
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.Returned protaper gold shaping file s1 25mm is actually broken at the tip of the active part (torque).No material defect was found during analysis of the rupture pattern.No unused file is available for evaluation.Nothing unusual to report was found during dhr review (batch #1662776).Root causes are not identified.We will track this kind of event and monitor the trend.
 
Event Description
In this event it was reported that a protaper gold file broke during first use.The broken piece could not be retrieved and was incorporated into the filling.No injury resulted.
 
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Brand Name
PROTAPER GOLD S1 25MM STER
Type of Device
FILE, PULP CANAL, ENDODONTIC
Manufacturer (Section D)
DENTSPLY MAILLEFER
chemin du verger 3
ballaigues, 1338
SZ  1338
MDR Report Key12630965
MDR Text Key276445460
Report Number8031010-2021-00229
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,other
Type of Report Initial
Report Date 10/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberA0410225G0103
Device Lot Number1662776
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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