BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-TEK MAXAN IMPLANTS

    MDR report key: 1377636 · Received March 6, 2009

    Report

    Report Number
    2242816-2009-00012
    Event Type
    Malfunction
    Date Received
    March 6, 2009
    Date of Event
    February 24, 2009
    Report Date
    February 26, 2009
    Manufacturer
    EBI, L.P.
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PART AND LOT NUMBER IS FOR THE SCREW THAT WAS NOT IMPLANTED. SPECIFICS ON THE PLATE WERE NOT AVAILABLE. DATE OF MANUFACTURE IS FOR THE SET SCREW NOT IMPLANTED. SPECIFICS ON THE PLATE WERE NOT AVAILABLE.

    Description of Event or Problem · 1

    WHILE PLACING THE FINAL SCREW INTO PLACE, THE LOCKING RING BECAME DISENGAGED FROM THE PLATE. ALL OTHER REMAINING SCREWS HAD ALREADY BEEN LOCKED. THE SURGEON DECIDED TO LEAVE THE PLATE IMPLANTED WITH NO ADVERSE REACTION EXPECTED. PATIENT'S OUTCOME: NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-TEK MAXAN IMPLANTS KWQ EBI, L.P. 598100

    Patients

    Seq Age Sex Outcome Treatment
    1