BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITANIUM CORTEX SCREW

    MDR report key: 6099295 · Received November 14, 2016

    Report

    Report Number
    6099295
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    August 17, 2016
    Report Date
    September 19, 2016
    Manufacturer
    SYNTHES (USA) PRODUCTS LLC
    Product Code
    DZL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SCREW HEAD REMOVED, SHAFT BROKE OFF AND COULD NOT BE REMOVED DUE TO THE SCAR TISSUE. SURGEON SHAVED DOWN THE SHAFT WITH THE DRILL TO SMOOTH THE SHAFT SO IT WOULD NOT PROTRUDE THROUGH THE TISSUE. CASE WAS A HARDWARE REMOVAL OF A TITANIUM SCREW. IT IS COMMON WHEN REMOVING TITANIUM SCREWS FOR THEM TO SHEAR OFF. IN THIS CASE, THE SCREW WAS BEING REMOVED FROM A MANDIBLE AND THE SCREWS ARE SMALL. IT IS THEN UP TO THE SURGEON TO DECIDE RISK VS BENEFIT OF TRYING TO REMOVE THE RETAINED SCREW SHAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749835 TITANIUM CORTEX SCREW SCREW, FIXATION, INTRAOSSEOUS DZL SYNTHES (USA) PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR