BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARRAY TI IMPLANTS

    MDR report key: 1627892 · Received March 10, 2010

    Report

    Report Number
    2242816-2010-00030
    Event Type
    Malfunction
    Date Received
    March 10, 2010
    Date of Event
    April 19, 2006
    Report Date
    January 18, 2010
    Manufacturer
    EBI, LLC
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT X-RAYS INDICATE A POST-OPERATIVE BROKEN SCREW SHAFT AT DISTAL END OF CONSTRUCT ON CONCAVE SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARRAY TI IMPLANTS SCREW MNI EBI, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR