BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOPLEX IMPLANT

    MDR report key: 617688 · Received June 28, 2005

    Report

    Report Number
    2029012-2005-00035
    Event Type
    Other
    Date Received
    June 28, 2005
    Report Date
    June 28, 2005
    Manufacturer
    INTERPORE CROSS INTERNATIONAL
    Product Code
    JDK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT FRACTURED DURING INITIAL PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPLEX IMPLANT CEMENT RESTRICTOR JDK INTERPORE CROSS INTERNATIONAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other