BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED V-MOUNT COUPLER

    MDR report key: 144716 · Received January 19, 1998

    Report

    Report Number
    1030489-1997-00212
    Event Type
    Injury
    Date Received
    January 19, 1998
    Report Date
    December 12, 1997
    Manufacturer
    SOFAMOR DANEK MEDICAL, INC.
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ONE HOUR INTO PROCEDURE THE PT COUGHED CAUSING A BLEED AND THE SCOPE TO BECOME FOGGY, WHICH NECESSITATED CONVERTING TO AN OPEN PROCEDURE. DURING OPEN PROCEDURE A DURAL TEAR OCCURRED, WHICH WAS NOT ATTRIBTURED TO THE INSTRUMENT BUT WHICH CAUSE A SIGNIFICANT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED V-MOUNT COUPLER COUPLER HRX SOFAMOR DANEK MEDICAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other