BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAK/C

    MDR report key: 1485821 · Received July 28, 2009

    Report

    Report Number
    2184052-2009-00038
    Event Type
    Malfunction
    Date Received
    July 28, 2009
    Date of Event
    October 19, 2006
    Report Date
    October 24, 2006
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEWED. REVIEW OF DEVICE HISTORY RECORDS INDICATE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THIS MDR IS BEING SUBMITTED LATE AS THIS ISSUE WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINT FILES CONDUCTED IN-CONJUNCTION WITH IMPLEMENTATION OF REVISED MDR REPORTING CRITERIA FOR ZIMMER

    Description of Event or Problem · 1

    THE CAGE WAS NOT IMPLANTED DEEP ENOUGH SO THE SURGEON WENT BACK TO FURTHER SEAT THE CAGE. THE DRIVER WAS NOT FULLY ENGAGED WHEN THE SURGEON ROTATED THE DRIVER AT WHICH TIME ONE OF THE DISTAL TANGS BROKE OFF. THE BROKEN PIECES WAS RETRIEVED. LESS THAN 10 MINUTES WAS ADDED TO SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAK/C IMPLANT DRIVER LXH ZIMMER SPINE, INC. 6200-0022-00 P010241

    Patients

    Seq Age Sex Outcome Treatment
    1