BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANI BARBED BROACHES

    MDR report key: 17477910 · Received August 8, 2023

    Report

    Report Number
    3002692886-2023-00003
    Event Type
    Injury
    Date Received
    August 8, 2023
    Date of Event
    June 25, 2023
    Report Date
    August 8, 2023
    Manufacturer
    MANI HANOI CO. LTD
    Product Code
    EKW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A ROOT CANAL PROCEDURE, A NEW BARBED BROACH BROKE OFF AND REMAINED IN THE CANAL. THE DENTIST HAD TO EXTRACT THE TOOTH IN ORDER TO REMOVE THE BROKEN BROACH. AS A RESULT OF THE COMPLAINT INVESTIGATION, THE RETURNED PRODUCTS( FROM SAME LOT RETURNED FROM USER) WERE CONFIRMED TO BE MANI PRODUCTS, THE APPEARANCE AND DIMENSIONS, AS WELL AS THE RESULTS OF TORSION AND BENDING TESTS, WERE ALL WITHIN THE STANDARD VALUES, ALSO NO PROBLEMS WERE IDENTIFIED. THEREFORE, WE JUDGED THAT THE FRACTURE MAY HAVE BEEN CAUSED BY EXCESSIVE LOAD APPLIED DURING USE OR BY BEING PUSHED HARDLY INTO THE ROOT CANAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1480848 MANI BARBED BROACHES BROACH, ENDODONTIC EKW MANI HANOI CO. LTD 00 B22C001800

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Required Intervention