BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE SYSTEM

    MDR report key: 1899488 · Received November 4, 2010

    Report

    Report Number
    1030489-2010-01439
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 5, 2010
    Manufacturer
    SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    MAX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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# 2991232, 510K# K073291 WAS CLEARED IN THE UNITED STATES. THE CAGE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVAL. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE CAGE WAS IMPLANTED INTO THE L5-S1 DISC SPACE, THE SURGEON WANTED TO REPOSITION THE CAGE AS IT WAS A LITTLE BIT TOO FAR IN THE DISC SPACE. THE DEVICE COULD NOT BE REPOSITIONED AS THE END OF IT WAS BROKEN. NO LOOSE PARTS OF THE DEVICE REMAIN IN THE PT. THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSTONE SYSTEM CAGE MAX SOFAMOR DANEK DEGGENDORF GMBH NA NS42

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR