BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAK

    MDR report key: 1485830 · Received July 28, 2009

    Report

    Report Number
    2184052-2009-00025
    Event Type
    Malfunction
    Date Received
    July 28, 2009
    Date of Event
    March 18, 2006
    Report Date
    March 29, 2006
    Manufacturer
    ZIMMER SPINE, INC.
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    WHILE IMPLANTING THE CAGE, ONE OF THE DISTAL TANGS BROKE OFF THE DRIVER. THE CAGE WAS NOT LOADED ONTO THE DRIVER PROPERLY. THE BROKEN TANG WAS REMOVED. THE CAGE WAS SUCCESSFULLY IMPLANTED, WITH NO ADDITIONAL SURGERY TIME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAK POSTERIOR IMPLANT DRIVER, 11MM HXX ZIMMER SPINE, INC. 07.00011.001 P010850

    Patients

    Seq Age Sex Outcome Treatment
    1