BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGEONE FIRE

    MDR report key: 18871387 · Received March 8, 2024

    Report

    Report Number
    3008857765-2024-00002
    Event Type
    Malfunction
    Date Received
    March 8, 2024
    Date of Event
    February 5, 2024
    Report Date
    March 8, 2024
    Manufacturer
    US ENDODONTICS LLC
    Product Code
    EKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS USED OUTSID EOF THE RECOMENDED SETTING ON HAND PIECE. DISTRIBUTOR MADE CLINICIAN AWARE OF THE DISCREPANCIES. FOLLOW-UP HAS YET TO BE MADE.

    Description of Event or Problem · 0

    EDIE (CONTACT AT DAVIDSON DENTISTRY) CONTACTED A DISTRIBUTION CANTER TO LET THEM KNOW THAT THEY HAD A FILE BREAK 3MM FROM THE TIP, WHILE THE PROCEDURE WAS BEING PREFORMED. THE PIECE WAS NOT REMOVED FROM THE CANAL AND WAS PACKED AROUND AND SEALED. THE FOLLOW UP APPOINTMENT HAS YET TO BE MADE, AND CAN BE A MONTH OR TWO FROM DATE. CLINICIAN ASKED FOR A REPLACEMENT PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160172 EDGEONE FIRE ENDODONTIC FILE EKS US ENDODONTICS LLC EOFPRI21 092923608

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown