BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES

    MDR report key: 2423767 · Received January 13, 2012

    Report

    Report Number
    MW5023860
    Event Type
    Injury
    Date Received
    January 13, 2012
    Date of Event
    November 30, 2011
    Report Date
    January 13, 2012
    Manufacturer
    SYNTHES, INC.
    Product Code
    KTT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE MD WAS PLACING THE SCREW IN THE PATIENT'S RIGHT SIDE, THE SCREW BENT. WHILE REMOVING THE SCREW, IT BROKE. A SCREW REMOVAL TRAY WAS CALLED FOR AND THE SCREW WAS REMOVED WITHOUT INCIDENT. THE PROCEDURE WENT ON WITHOUT FURTHER COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNTHES 6.5X90MM 4MM HEXAGONAL SOCKET SCREW KTT SYNTHES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention