BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXAN IMPLANTS

    MDR report key: 1904943 · Received November 22, 2010

    Report

    Report Number
    2242816-2010-00171
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    EBI, LLC
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RING IN THE PLATE BECAME DISLODGED WHILE INSERTING A FIXED SCREW. THE PLATE AND ALL SCREWS WERE REMOVED AND REPLACED WITH A NEW PLATE. PATIENT OUTCOME: NO ADVERSE EFFECT REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXAN IMPLANTS 1 LEVEL 12MM PLATE KWQ EBI, LLC 13263J

    Patients

    Seq Age Sex Outcome Treatment
    1