BEUDAMED
    FDA Adverse Event Other Summary report: N

    1.7 X 6MM SELF DRILLING SCREW

    MDR report key: 547247 · Received October 1, 2004

    Report

    Report Number
    547247
    Event Type
    Other
    Date Received
    October 1, 2004
    Date of Event
    September 27, 2004
    Report Date
    October 1, 2004
    Manufacturer
    STRYKER LEIBINGER, INC.
    Product Code
    HXX
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT, WITH LEFT MAXILLARY SINUS CANCER WAS UNDERGOING A LEFT MAXILLECTOMY AND RECONSTRUCTION UNDER STEREOTACTIC CT GUIDANCE. DURING THE ATTACHMENT OF THE GUIDANCE STAR, ONE OF THE 6 MM X 1.7 SELF TAPPING, SELF DRILLING SCREW HEADS SHEARED OFF. THERE WAS NO SEQUELA TO THE PATIENT, AND IT IS UNCLEAR WHETHER THIS WAS A DEVICE ISSUE OR USER ERROR. THE SALES REPRESENTATIVE WAS PRESENT, AND SENT THE SCREW HEAD TO THE COMPANY FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.7 X 6MM SELF DRILLING SCREW 1.7 X 6MM SELF DRILLING SCREW HXX STRYKER LEIBINGER, INC. 51-17906 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR