BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACF DISTRACTION SCREW 12MM ONE

    MDR report key: 1220334 · Received November 3, 2008

    Report

    Report Number
    2430952-2008-00032
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Report Date
    November 3, 2008
    Manufacturer
    INSTRUMED INTERNATIONAL
    Product Code
    MQP
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THEY ARE RETURNING 6 EACH OF (B) (4). IT SHOULD BE A 12MM DISTRACTION SCREW, PACKAGING ERROR, CUSTOMER RECEIVED 16MM SCREWS IN THE 12MM PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACF DISTRACTION SCREW 12MM ONE VERTEBRAL BODY DISTRACTION SYSTEM MQP INSTRUMED INTERNATIONAL 326081

    Patients

    Seq Age Sex Outcome Treatment
    1