BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-TEK MAXAN

    MDR report key: 2097460 · Received May 20, 2011

    Report

    Report Number
    2242816-2011-00045
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Manufacturer
    EBI, LLC
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ATTACHED RESPONSE IS IN REGARDS TO THE LETTER SENT TO BIOMET BY (B)(4).

    Description of Event or Problem · 1

    ATTACHED IS A RESPONSE TO AN FDA REQUEST FOR MORE INFORMATION REGARDING THE FOLLOWING MDRS: 2242816-2010-00144, 2242816-2010-00132, 2242816-2010-00008, 2242816-2009-00090, 2242816-2009-00072, 2242816-2009-00053, 2242816-2009-00052, 2242816-2009-00014, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-TEK MAXAN MAXAN PLATES KWQ EBI, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1