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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY MAILLEFER K-FILE COLORINOX S 25MM 008; FILE, PULP CANAL, ENDODONTIC
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DENTSPLY MAILLEFER K-FILE COLORINOX S 25MM 008; FILE, PULP CANAL, ENDODONTIC Back to Search Results
Catalog Number S206100190202
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.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 008
Type of Device
FILE, PULP CANAL, ENDODONTIC
Manufacturer (Section D)
DENTSPLY MAILLEFER
chemin du verger 3
ballaigues, 1338
SZ  1338
MDR Report Key12719273
MDR Text Key279014419
Report Number8031010-2021-00254
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberS206100190202
Device Lot Number1708118
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2021
Initial Date Manufacturer Received 10/01/2021
Initial Date FDA Received10/29/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
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