BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARRAY IMPLANTS

    MDR report key: 2133230 · Received June 20, 2011

    Report

    Report Number
    2242816-2011-00066
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Report Date
    May 25, 2011
    Manufacturer
    EBI, LLC
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, "POSSIBLE ADVERSE EFFECTS: INCLUDE:"BENDING, FRACTURE LOOSENING OR MIGRATION OF THE IMPLANT..."

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT TWO SCREWS IMPLANTED ARE BROKEN.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 IMPLANTS 5.5X40MM SCREWS MNI EBI, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1