BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAK LUMBAR

    MDR report key: 1485812 · Received July 28, 2009

    Report

    Report Number
    2184052-2009-00050
    Event Type
    Malfunction
    Date Received
    July 28, 2009
    Report Date
    September 21, 2007
    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 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 IMPLANT WAS LOADED ONTO THE DRIVER AND THEN PASSED DOWN THE DRILL TUBE. THE DRIVER GOT STUCK AND WOULD NOT ADVANCE ANY FURTHER DOWN THE TUBE. THE SURGEON FORCEFULLY TURNED THE DRIVER CLOCKWISE AT WHICH TIME THE TIP OF THE DRIVER BROKE OFF. THE DRILL TUBE WAS REMOVED AND THE BROKEN PIECE OF THE DRIVER RETRIEVED. SURGERY WAS COMPLETED WITH ANOTHER DRIVER. THER WAS LESS THAN 10 MINUTES ADDITIONAL SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAK LUMBAR IMPLANT DRIVER, 9MM LXH ZIMMER SPINE, INC. 4022-3006-00 P010418

    Patients

    Seq Age Sex Outcome Treatment
    1