BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED V-MOUNT COUPLER

    MDR report key: 114775 · Received August 21, 1997

    Report

    Report Number
    1030489-1997-00045
    Event Type
    Injury
    Date Received
    August 21, 1997
    Date of Event
    June 19, 1997
    Report Date
    June 30, 1997
    Manufacturer
    SOFAMOR DANEK MEDICAL, INC.
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COUPLER WOULD NOT FOCUS. DOCTOR HAD TO PERFORM AN OPEN PROCEDURE.

    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 UNKNOWN Required Intervention