BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 1520856 · Received October 29, 2009

    Report

    Report Number
    1030489-2009-01010
    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
    HWC
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE LOT NUMBERS USED ARE LOT # H08K9497 AND H08K9498. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 9791223, 510K # K061274 WAS CLEARED IN THE UNITED STATES. MANUFACTURE DATE FOR BOTH LOTS ARE 11/20/2008. THE IMPLANTS REMAIN IMPLANTED, PRODUCT RETURN IS NOT POSSIBLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT AN ACF AT C3-C6 BY SUBTOTAL CORPECTOMY AT C4 AND C5, IMPLANTING ANTERIOR CERVICAL PLATE SYSTEM. IT WAS REPORTED THAT WHEN THE SURGEON INSERTED THE SCREW AT LEFT C3, THE SCREWDRIVER SLIPPED AND DAMAGED THE SCREW HEAD. SINCE THE SURGEON COULD NOT INSERT THE SCREW DEEPER, THE LOCKING WASHER WAS INEVITABLY NOT ON THE SCREW HEAD. NO PT COMPLICATIONS WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTURE ANTERIOR CERVICAL PLATE SYSTEM BONE SCREW HWC MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other