BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGEFILE X7

    MDR report key: 20540030 · Received October 25, 2024

    Report

    Report Number
    3008857765-2024-00004
    Event Type
    Malfunction
    Date Received
    October 25, 2024
    Date of Event
    August 29, 2024
    Report Date
    October 25, 2024
    Manufacturer
    US ENDODONTICS, LLC.
    Product Code
    EKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    N/A.

    Description of Event or Problem · 0

    FILE BROKE DURING PROCEDURE APPROXIMATELY 3-5 MM REMAINED IN THE CANAL. BROKEN PIECE WAS NOT REMOVED. CLINICIAN BYPASSED AND FILLED AROUND BROKEN PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820191 EDGEFILE X7 ENDODONTIC FILE EKS US ENDODONTICS, LLC. X7170425RF 021724133

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown