BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDGESEQUEL SAPPHIRE

    MDR report key: 17057237 · Received June 5, 2023

    Report

    Report Number
    3008857765-2023-00001
    Event Type
    Injury
    Date Received
    June 5, 2023
    Date of Event
    January 27, 2021
    Report Date
    May 31, 2023
    Manufacturer
    US ENDODONTICS, LLC
    Product Code
    EKS
    PMA / PMN Number
    N/AN/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    "CLINICIAN WAS CONDUCTING A ROOT CANAL PROCEDURE USING AN EDGESEQUEL SAPPHIRE ENDODONTIC FILE. THE FILE SEPARATED WHICH RESULTED IN THE CLINICIAN DECIDING TO EXTRACT THE TOOTH DURING A SEPARATE APPOINTMENT. NO PICTURES OR X-RAYS WERE PROVIDED AS SUPPORTING EVIDENCE. THE CLINICIAN REPORTED DISCARDING THE SEPARATED FILE AND INTENDS TO RETURN THE REMAINDER OF THE ENDODONTIC FILE ORDER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182398 EDGESEQUEL SAPPHIRE ENDODONTIC FILE EKS US ENDODONTICS, LLC ES300425 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability