BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEXTANT SPINAL SYSTEM

    MDR report key: 1520854 · Received October 29, 2009

    Report

    Report Number
    1030489-2009-01012
    Event Type
    Malfunction
    Date Received
    October 29, 2009
    Date of Event
    September 29, 2009
    Report Date
    September 29, 2009
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MCV
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE LIKE DEVICE CATALOG #8675300, 510K #K001255 AND CATALOG #7576301 THROUGH 7576305, 510K #K063417 WAS CLEARED IN THE UNITED STATES. THE INSTRUMENT WAS NOT RETUNED TO THE MFR FOR EVAL. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A PROCEDURE AT L4/5 USING MINI-INVASIVE PROCEDURE TO INSERTER POSTERIOR FIXATION. THE SCREW CAME OFF FROM THE SCREW EXTENDER WHEN INSTALLING THE PLUG AFTER REDUCTION. THE SURGEON COULD NOT BREAK OFF THE PLUG IN THE SCREW EXTENDER, HE USED A COUNTER TORQUE TO BREAK THE PLUG'S TAB OFF. NO OTHER COMPLICATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEXTANT SPINAL SYSTEM EXTENDER MCV MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR