BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN

    MDR report key: 5400088 · Received January 30, 2016

    Report

    Report Number
    2411236-2016-00001
    Event Type
    Injury
    Date Received
    January 30, 2016
    Date of Event
    January 4, 2016
    Report Date
    January 4, 2016
    Manufacturer
    MANI HANOI CO., LTD.
    Product Code
    EKS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT WHILE PERFORMING A ROOT CANAL PROCEDURE WITH THE ENDOFLEX K-FILE IT BROKE AND GOT STUCK INSIDE THE PATIENT'S CANAL. THE DENTIST TOOK AN X-RAY AND WAS UNABLE TO RETRIEVE THE FILE; THEREFORE THE PATIENT WAS REFERRED TO AN ORAL SURGEON TO HAVE IT REMOVED. THE BROKEN FILE WAS SUCCESSFULLY REMOVED. THE LOT NUMBER WAS NOT PROVIDED BECAUSE THE PACKAGE WHICH CONTAINED THE LOT NUMBER WAS DISCARDED BY THE END USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58426 HENRY SCHEIN ENDOFLEX K-FILES 25 MM EKS MANI HANOI CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other