BEUDAMED
    FDA Adverse Event Other Summary report: N

    MALIBU POLYAXIAL SCREW 6.5 X 50

    MDR report key: 1286784 · Received January 8, 2009

    Report

    Report Number
    2032593-2008-00003
    Event Type
    Other
    Date Received
    January 8, 2009
    Date of Event
    July 2, 2008
    Report Date
    January 7, 2009
    Manufacturer
    SEASPINE, INC.
    Product Code
    KWP
    PMA / PMN Number
    K072605
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HARDWARE REMOVAL/REPLACEMENT. SCREW HAS BROKEN INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALIBU POLYAXIAL SCREW 6.5 X 50 888.3070 PEDICAL SCREW SPINAL SYSTEM KWP SEASPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention