BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARRAY PEDICLE SCREW

    MDR report key: 697188 · Received March 27, 2006

    Report

    Report Number
    MW1038353
    Event Type
    Injury
    Date Received
    March 27, 2006
    Date of Event
    March 8, 2006
    Report Date
    March 27, 2006
    Manufacturer
    EBI
    Product Code
    MCV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ARRAY SYSTEM PEDICLE SCREW BROKE AFTER BEING IMPLANTED IN PT IN 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARRAY PEDICLE SCREW ORTHOPEDIC SCREW MCV EBI EBI 116750 6.5 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Disability