BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIONX IMPLANTS LTD

    MDR report key: 416518 · Received September 10, 2002

    Report

    Report Number
    416518
    Event Type
    Malfunction
    Date Received
    September 10, 2002
    Date of Event
    September 3, 2002
    Report Date
    September 10, 2002
    Manufacturer
    BIONX IMPLANTS LTD
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD ARTHROPLASTY AND RETURNED TO HAVE BROKEN PIN REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIONX IMPLANTS LTD ARTHROPLASTY PIN MAI BIONX IMPLANTS LTD REF-223524 1569

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other