BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD

    MDR report key: 26611 · Received August 3, 1995

    Report

    Report Number
    26611
    Event Type
    Malfunction
    Date Received
    August 3, 1995
    Date of Event
    April 21, 1995
    Report Date
    May 1, 1995
    Manufacturer
    RICHARDS MEDICAL CO., INC.
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BROKEN HARDWARE REMOVED FROM PT (ROD LEFT FEMUR). NON UNION OF DISTAL FEMUR-RETURNED TO O.R. FOR REPLACEMENT OF ROD. ORIGINAL SURGERY NOT DONE HERE. I.D. NUMBERS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROD ROD HSB RICHARDS MEDICAL CO., INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other