BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAK INSTRUMENTATION

    MDR report key: 180746 · Received August 3, 1998

    Report

    Report Number
    2184052-1998-00003
    Event Type
    Injury
    Date Received
    August 3, 1998
    Date of Event
    November 20, 1997
    Report Date
    August 3, 1998
    Manufacturer
    SULZER SPINE-TECH
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A VASCULAR INJURY OCCURRED DURING ANTERIOR IMPLANTATION OF THE BAK IMPLANT. THE IMPLANTS WERE INSERTED WITHOUT INCIDENT. UPON REMOVAL OF THE DRILL TUBE, A VASCULAR INJURY WAS DETECTED. DURING REPAIR OF THE VESSEL, A LARGE AMOUNT OF BLOOD WAS LOST.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention