BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXAN IMPLANTS

    MDR report key: 1850578 · Received October 1, 2010

    Report

    Report Number
    2242816-2010-00126
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 2010
    Manufacturer
    EBI, LLC
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGERY RING POPPED OUT OF THE 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 3 LEVEL 51MM PLATE KWQ EBI, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1