BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNESYS TOP LOADING

    MDR report key: 1348821 · Received February 6, 2009

    Report

    Report Number
    2184052-2009-00005
    Event Type
    Malfunction
    Date Received
    February 6, 2009
    Date of Event
    December 31, 2008
    Report Date
    January 7, 2009
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS REVIEWED. REVIEW OF DEVICE HISTORY RECORDS INDICATE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. INITIAL EVAL DETERMINED THAT THE BLADE HOLDER PIVOT SCREW DID NOT MAINTAIN PROPER POSITION. IT WAS ALSO IDENTIFIED THAT THE SCREW AND MARKINGS WHICH SUGGEST IT WAS TAMPERED WITH. ADDITIONAL EVAL IS BEING CONDUCTED TO DETERMINE THE ROOT CAUSE.

    Description of Event or Problem · 1

    THE SURGEON SUCCESSFULLY CUT ONE SPACER, WHEN THE SURGEON ATTEMPTED TO CUT THE SECOND SPACER, THE SPACER CUTTER WAS JAMMED AND UNUSABLE. AN ALTERNATIVE METHOD WAS USED TO CUT THE REMAINING SPACER(S) WHICH ADDED AN ADDITIONAL 30-45 MINUTES TO THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNESYS TOP LOADING DTL SPACER CUTTER LXH ZIMMER SPINE, INC. 07.01284.001 60970745

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR