BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL ROD

    MDR report key: 128920 · Received October 24, 1997

    Report

    Report Number
    128920
    Event Type
    Injury
    Date Received
    October 24, 1997
    Date of Event
    June 10, 1997
    Report Date
    September 5, 1997
    Manufacturer
    DANEK MEDICAL, INC.
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SPINE STABILIZATION ROD BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL ROD Implant SPINAL ROD HSB DANEK MEDICAL, INC. 808.085 65404

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention