BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAK INSTRUMENTATION

    MDR report key: 173007 · Received June 15, 1998

    Report

    Report Number
    2184052-1998-00002
    Event Type
    Injury
    Date Received
    June 15, 1998
    Date of Event
    May 20, 1998
    Report Date
    June 12, 1998
    Manufacturer
    SULZER SPINE-TECH
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING PREPARATION FOR IMPLANT PLACEMENT, THE INSTRUMENT WAS INADVERTENTLY TITLED AND THE VENA CAVA AND LEFT ILIAC VESSEL ENTERED THE IMPLANT INSERTION FIELD. THE VENA CAVA AND THE LEFT ILIAC VESSEL WERE THEN CAUGHT BETWEEN THE IMPLANT AND THE INSTRUMENT AND SUBSEQUENTLY DAMAGED WHEN THE IMPLANT WAS ADVANCED. THE IMPLANT WAS NOT FULLY IMPLANTED, THEREFORE REMOVED TO FACILITATE THE REPAIR OF THE VESSELS. THE PT LOST A LARGE AMOUNT OF BLOOD DURING THE REPAIR OF THESE VESSELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAK INSTRUMENTATION ADJUSTABLE DRILL TUBE LXH SULZER SPINE-TECH NA P970098

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention