BEUDAMED
    FDA Adverse Event Other Summary report: N

    MALIBU

    MDR report key: 2300516 · Received October 6, 2011

    Report

    Report Number
    2032593-2011-00004
    Event Type
    Other
    Date Received
    October 6, 2011
    Date of Event
    September 7, 2011
    Report Date
    October 6, 2011
    Manufacturer
    SEASPINE
    Product Code
    NKB
    PMA / PMN Number
    K051663
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L MODEL# 12-1040. ADD'L CATALOG#: 12-1040, ADD'L LOT# Z9833C.

    Description of Event or Problem · 1

    REPRESENTATIVE REPORTED THAT AN L4-L5 FUSION TOOK PLACE TWO WEEKS AGO AND WHEN AN X-RAY WAS TAKEN ON (B)(6) 2011 IT SHOWED THE ROD HAD DISLODGED FROM THE LEFT SIDE OF THE INFERIOR SCREW. A REVISION WAS DONE ON (B)(6) 2011 AS A RESULT. AT THIS TIME THERE HAS BEEN NO FURTHER INFO FROM THE REP. ONCE THE INFO IS RECEIVED, A F/U REPORT WILL BE DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALIBU SPINAL INTERLAMINAL FIXATION ORTHOSIS NKB SEASPINE 12-6550 A1603A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention