BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALIBU DLTA SCREW 4.5 X 30 MM

    MDR report key: 2433641 · Received January 10, 2012

    Report

    Report Number
    2032593-2011-00023
    Event Type
    Malfunction
    Date Received
    January 10, 2012
    Date of Event
    November 23, 2011
    Report Date
    January 10, 2012
    Manufacturer
    SEASPINE, INC.
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER STATED, "AS THEY TRIED PLACING 3 DIFFERENT LOCKING CAPS ON THE SCREW WITHOUT SUCCESS THE SCREW WAS SUBSTITUTED BY ANOTHER ONE AND TRIED WITH THE SAME CAPS AND IT WORKED." THE SURGEON HAD TO REMOVE THE ROD AND ALL THE CAPS ALREADY IMPLANTED AND REPLACE THE SCREW. SURGERY WAS COMPLETED WITH NO HARM TO THE PT AND NO BREAKAGE OR FRAGMENTS INTO THE INCISION. THERE WAS A DELAY IN SURGERY OF A HALF HOUR OR MORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALIBU DLTA SCREW 4.5 X 30 MM MALIBU KWP SEASPINE, INC. MO10207B

    Patients

    Seq Age Sex Outcome Treatment
    1