BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 421956 · Received October 3, 2002

    Report

    Report Number
    421956
    Event Type
    Malfunction
    Date Received
    October 3, 2002
    Date of Event
    October 13, 1999
    Report Date
    September 9, 2002
    Manufacturer
    BIONX IMPLANTS INC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    SCREWS IMPLANTED IN 1999. RECENTLY PT HAS REQUIRED REMOVAL OF THESE SCREWS DUE TO PAIN COMPLAINTS FROM THE SCREW MIGRATION OUTWARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * HWC BIONX IMPLANTS INC * 849

    Patients

    Seq Age Sex Outcome Treatment
    1 *