BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGETAPER

    MDR report key: 22359738 · Received June 30, 2025

    Report

    Report Number
    3008857765-2025-00001
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Date of Event
    April 30, 2025
    Report Date
    June 27, 2025
    Manufacturer
    US ENDODONTICS, LLC.
    Product Code
    EKS
    UDI-DI
    00819514029892
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    THE FILE FRACTURED DURING AN ENDODONTIC TREATMENT (FRACTURE OCCURRED IN THE PATIENT'S MOUTH). THE AFFECTED PATIENT WAS NOT INJURED, AND NO MEDICAL CARE WAS REQUIRED. THE INCIDENT OCCURRED 20 MINUTES AFTER THE START OF THE TREATMENT. THE DENTIST STATED THAT THE INCIDENT HAPPENED DURING THE FIRST USE OF THE PRODUCT AND THAT THEY HAVE EXPERIENCE USING THIS PRODUCT, AS WELL AS A SIMILAR PRODUCT FROM RARE EUO. THE PRACTITIONER STATED THAT THEY DID NOT STERILIZE THE PRODUCT BEFORE USE. THE CLEANING PROTOCOL CONSISTED OF DISINFECTION AND LUBRICATION. REGARDING THE SEX OF THE AFFECTED PATIENT, THE DENTIST INDICATED BOTH MALE AND FEMALE. A REQUEST FOR CLARIFICATION HAS BEEN SENT TO DETERMINE IF MULTIPLE PATIENTS WERE INVOLVED. THE BROKEN FRAGMENTS COULD NOT BE REMOVED. THE SETTINGS USED WERE: POWER - 350 RPM, SPEED + 30 - 150, HANDPIECE USED FKG. THE CANNULA WAS BENT BEFORE INJECTION. THE FILES WERE DISCARDED (NO SAMPLE AVAILABLE FOR INVESTIGATION).QUANTITY OF PARTS IMPACTED BY THE DEFECT: 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837613 EDGETAPER ENDODONTIC ROTARY FILE EKS US ENDODONTICS, LLC. SETF225 012522119 00819514029892

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention