BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRN SYSTEM IMPLANT

    MDR report key: 26400 · Received July 31, 1995

    Report

    Report Number
    26400
    Event Type
    Injury
    Date Received
    July 31, 1995
    Date of Event
    June 6, 1995
    Report Date
    June 30, 1995
    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

    ADD'L OTHER #: 6.5X45.FRACTURED BILATERAL S1 PEDICLE SCREWS WERE SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSRN SYSTEM IMPLANT Implant PEDICLE SCREWS MCV DANEK MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization