BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-TEK MAXAN IMPLANTS

    MDR report key: 1380869 · Received March 20, 2009

    Report

    Report Number
    2242816-2009-00015
    Event Type
    Malfunction
    Date Received
    March 20, 2009
    Date of Event
    March 11, 2009
    Report Date
    March 13, 2009
    Manufacturer
    EBI, LLC
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DETAIL FOR SECOND PART; MODEL#: 14-521220, LOT #: 13541J. MANUFACTURE DATE FOR MODEL# 14-521220: 10/2008. DHR WERE REVIEWED FOR BOTH PARTS. NO DISCREPANCIES WERE FOUND.

    Description of Event or Problem · 1

    DURING SURGERY, A RING CAME OUT OF THE PLATE. THE PLATE WAS REMOVED AND A SECOND PLATE WAS ATTEMPTED. RING CAME OUT OF SECOND PLATE AND PLATE WAS SUBSEQUENTLY REMOVED. PROCEDURE WAS COMPLETED WITH A COMPETITIVE PRODUCT. PATIENT OUTCOME: NO ADVERSE EFFECT ON PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-TEK MAXAN IMPLANTS KWQ EBI, LLC 13545J

    Patients

    Seq Age Sex Outcome Treatment
    1