BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-TEK MAXAN ANTERIOR PLATING SYSTEM

    MDR report key: 2062851 · Received April 19, 2011

    Report

    Report Number
    2242816-2011-00035
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    EBI, LLC
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CATALOG NUMBERS / LOT NUMBERS: P/N 14-521456 QTY 1, LOT #14752S, P/N 14-521452 QTY 1, LOT #14751S, P/N 14-521644 QTY 2, LOT #949660, 715970, P/N 14-521642 QTY 3, LOT #590240, 878130, P/N 14-521612 QTY 1, LOT #004880.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RINGS OF THE PLATE CAME OUT AS THE SURGEON WAS INSERTING THE SCREWS. PATIENT OUTCOME: THE REPORT INDICATES THAT THE PATIENT STATUS IF FINE. NO ADVERSE EFFECTS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-TEK MAXAN ANTERIOR PLATING SYSTEM C-TEK MAXAN 64MM PLATE KWQ EBI, LLC 14754S

    Patients

    Seq Age Sex Outcome Treatment
    1