BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN

    MDR report key: 6037928 · Received October 18, 2016

    Report

    Report Number
    2411236-2016-00005
    Event Type
    Injury
    Date Received
    October 18, 2016
    Date of Event
    September 12, 2016
    Report Date
    September 19, 2016
    Manufacturer
    HARALD NORDIN S.A.
    Product Code
    ELR
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IT
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT A GOLD PLATED SCREW POST BROKE WHILE SCREWING THE POST INSIDE THE ROOT CANAL DURING A DENTAL RESTORATION CROWN BUILD UP PROCEDURE ON A PATIENT. THE PROCEDURE WAS PERFORMED WITHOUT ANY PARTICULAR TORQUE FORCE WHEN THE POST BROKE WITHOUT THE POSSIBILITY TO REMOVE IT FROM THE ROOT CANAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688040 HENRY SCHEIN SCREW POST GOLD PLATED ELR HARALD NORDIN S.A. 15732

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other