BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARRAY TITANIUM IMPLANTS

    MDR report key: 1855188 · Received October 6, 2010

    Report

    Report Number
    2242816-2010-00140
    Event Type
    Injury
    Date Received
    October 6, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    EBI, LLC
    Product Code
    MNI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS CONDUCTED TO REMOVE A ROD AND BROKEN SCREW TWO YEARS POST-OP. PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARRAY TITANIUM IMPLANTS 5.5MMX510MM ROD MNI EBI, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention