BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEXTANT

    MDR report key: 1880815 · Received October 1, 2010

    Report

    Report Number
    1030489-2010-01283
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    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, A LIKE DEVICE CATALOG # 7576301, 510K # K063147 WAS CLEARED IN THE UNITED STATES. DEVICE WAS NOT RETURNED TO THE MFR FOR EVAL. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A PLIF USING MINI-INVASIVE PROCEDURE TO IMPLANT POSTERIOR FIXATION ROD AND SCREWS AT L4-L5. DURING THE REDUCTION PROCEDURE BILATERALLY AT L4, THE SCREW HEAD CAME OFF THE EXTENDER THREE CONSECUTIVE TIMES. THE SCREWS WERE CHANGED AND IMPLANTED. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEXTANT SCREW EXTENDER KWQ MEDTRONIC SOFAMOR DANEK NA DC08B014

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR