BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAK INSTRUMENTATION

    MDR report key: 182462 · Received August 13, 1998

    Report

    Report Number
    2184052-1998-00004
    Event Type
    Injury
    Date Received
    August 13, 1998
    Date of Event
    July 24, 1998
    Report Date
    August 12, 1998
    Manufacturer
    SULZER SPINE-TECH
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A VASCULAR INJURY OCCURRED DURING AN ANTERIOR BAK IMPLANTATION. AFTER REMOVAL OF THE STARTER REAMER, THE VASCULAR INJURY WAS IDENTIFIED. A LARGE AMOUNT OF BLOOD WAS LOST DURING REPAIR OF THE VESSEL. UPON REPAIR OF THE VESSEL, THE DISC SPACE WAS PACKED WITH BONE AND THE SURGERY WAS DISCONTINUED. THE EXACT CAUSE OF THE VESSEL INJURY WAS NOT DETERMINED.

    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 38 YR Required Intervention