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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY MAILLEFER PROTAPER ASSORT. 21MM; FILE, PULP CANAL, ENDODONTIC
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DENTSPLY MAILLEFER PROTAPER ASSORT. 21MM; FILE, PULP CANAL, ENDODONTIC Back to Search Results
Catalog Number A040922190112
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/23/2021
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.Involved product that broke during use was not returned and cannot be identified and analyzed.Moreover, no unused file is available for evaluation.Nothing unusual to report was found during dhr review.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 file broke while clearing the curved canal.The broken piece was retrieved by expanding the canal.No injury resulted.
 
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Brand Name
PROTAPER ASSORT. 21MM
Type of Device
FILE, PULP CANAL, ENDODONTIC
Manufacturer (Section D)
DENTSPLY MAILLEFER
chemin du verger 3
ballaigues, 1338
SZ  1338
MDR Report Key12727858
MDR Text Key279277115
Report Number8031010-2021-00261
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
Report Date 10/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberA040922190112
Device Lot Number1664734
Was Device Available for Evaluation? No
Date Manufacturer Received10/08/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
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