BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRYX INTERFERENCE SCREW

    MDR report key: 870222 · Received June 21, 2007

    Report

    Report Number
    9613278-2007-00025
    Event Type
    Malfunction
    Date Received
    June 21, 2007
    Date of Event
    January 11, 2007
    Report Date
    January 12, 2007
    Manufacturer
    CONMED LINVATEC BIOMATERIALS LTD
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE RECEIVED THE IMPLANT AND INVESTIGATION IS ONGOING. WE WILL PREPARE A FOLLOW - UP REPORT ACCORDING TO RESULTS OF THE INVESTIGATION. THE INITIAL REPORT WAS SENT TO CONMED LINVATEC, AND DUE TO LACK OF COMMUNICATION, WE BECAME AWARE OF THIS ON JUNE 1ST, 2007.

    Description of Event or Problem · 1

    DR TRIED TO IMPLANT THE SCREW INTO NORMAL FEMORAL BONE. BOTH SCREWS LOST MATERIAL AT THE HIP, WITHOUT THE INFLUENCE OF BENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MATRYX INTERFERENCE SCREW BIOABSORBABLE FIXATION DEVICE MAI CONMED LINVATEC BIOMATERIALS LTD S0002778

    Patients

    Seq Age Sex Outcome Treatment
    1 YR