BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAK/L

    MDR report key: 1547547 · Received November 12, 2009

    Report

    Report Number
    2184052-2009-00085
    Event Type
    Malfunction
    Date Received
    November 12, 2009
    Date of Event
    October 14, 2009
    Report Date
    October 14, 2009
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DIMENSIONAL ANALYSIS AND DEVICE HISTORY RECORD WAS REVIEWED. DIMENSIONAL ANALYSIS AND DHR OF THE DEVICE INDICATES THE DEVICE WAS MANUFACTURED TO SPECIFICATION.

    Description of Event or Problem · 1

    DURING SURGERY, THE PADDLE SNAPPED OFF DURING IMPACTION GOING THROUGH THE ANNULUS INTO THE ABDOMEN. THE SURGEON REMOVED BROKEN PADDLE AND COMPLETED THE SURGERY WITH A TOOTHED PADDLE TUBE. AN ADDITIONAL 16 TO 30 MINUTES WAS ADDED TO SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAK/L 13MM DISTAL TUBE KWP ZIMMER SPINE, INC. 4021-0180-00 P980104

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR