BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSTONE SPINAL SYSTEM

    MDR report key: 1030462 · Received April 17, 2008

    Report

    Report Number
    1030489-2008-00198
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 17, 2008
    Report Date
    March 18, 2008
    Manufacturer
    SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    MAX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED; THEREFORE, PRODUCT EVALUATION IS NOT POSSIBLE AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DOCUMENTATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS THE SURGEON WAS USING A HAMMER TO POSITION THE DEVICE, A SMALL PIECE OF THE DEVICE SNAPPED OFF INSIDE THE PT. THE SMALLER BROKEN PIECE WAS RETRIEVED AND THE SURGEON DECIDED TO LEAVE THE DAMAGED DEVICE IMPLANTED SINCE THE IMPLANT WAS "STILL INTACT AND WILL STILL SERVE PURPOSE." NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSTONE SPINAL SYSTEM SPACER MAX SOFAMOR DANEK DEGGENDORF GMBH NA NG36

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK