BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENEK

    MDR report key: 17931 · Received July 29, 1994

    Report

    Report Number
    17931
    Event Type
    Injury
    Date Received
    July 29, 1994
    Date of Event
    April 12, 1994
    Report Date
    April 14, 1994
    Manufacturer
    DANEK MEDICAL INC.
    Product Code
    MCV
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PEDICLE SCREW BROKE AND HAD TO BE REMOVED FROM VERTEBRAL. FUSION WAS COMPLETE, NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DENEK Implant PEDICLE SCREWS MCV DANEK MEDICAL INC. 808845 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization