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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY MAILLEFER K-FILE COLORINOX S 25MM 010; FILE, PULP CANAL, ENDODONTIC
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DENTSPLY MAILLEFER K-FILE COLORINOX S 25MM 010; FILE, PULP CANAL, ENDODONTIC Back to Search Results
Catalog Number S206100190302
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.Involved product broken during use was not returned and cannot be analyzed.Nothing unusual to report was found during dhr review.Ten of the unused k-files colorinox 25mm 010 have been evaluated and the products were found in compliance with specifications.No fault found, production meets specifications.
 
Event Description
In this event, a customer reported that a k-file colorinox file broke during use.No injury resulted.No information available regarding part retrieved or not from the patient's mouth.
 
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Brand Name
K-FILE COLORINOX S 25MM 010
Type of Device
FILE, PULP CANAL, ENDODONTIC
Manufacturer (Section D)
DENTSPLY MAILLEFER
chemin du verger 3
ballaigues, 1338
SZ  1338
MDR Report Key12719287
MDR Text Key279027142
Report Number8031010-2021-00256
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 health professional
Type of Report Initial
Report Date 10/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberS206100190302
Device Lot Number1705429
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2021
Date Manufacturer Received10/01/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
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