BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELBY SPINALL IMPLANT

    MDR report key: 18380 · Received December 13, 1994

    Report

    Report Number
    MW1004426
    Event Type
    Injury
    Date Received
    December 13, 1994
    Date of Event
    May 27, 1992
    Report Date
    December 5, 1994
    Manufacturer
    ADVANCED SPINE FIXATION SYSTEMS, INC.
    Product Code
    MCV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR WAS DRIVING WHEN HE FELT A BAD PAIN ON THE LEFT SIDE RADIATING INTO THE RIGHT HIP AND LEG. RPTR WENT TO THE ER AND DR FOUND THE BROKEN ROD ON THE LEFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELBY SPINALL IMPLANT Implant MCV ADVANCED SPINE FIXATION SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other| R