BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOPLEX IMPLANT

    MDR report key: 609957 · Received June 2, 2005

    Report

    Report Number
    2029012-2005-00023
    Event Type
    Other
    Date Received
    June 2, 2005
    Date of Event
    April 28, 2005
    Report Date
    June 2, 2005
    Manufacturer
    INTERPORE CROSS INTERNATIONAL
    Product Code
    JDK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A BIOPLEX IMPLANT WAS FRACTURED AS IT WAS BEING IMPACTED DURING SURGERY. ANOTHER IMPLANT OF THE SAME TYPE WAS USED TO COMPLETE THE CASE UNEVENTFULLY. THERE WAS NO COMPLICATION AND/OR INJURY TO PATIENT. PATIENT DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPLEX IMPLANT CEMENT RESTRICTOR JDK INTERPORE CROSS INTERNATIONAL NA 403909

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other| R