BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOPLEX C IMPLANT

    MDR report key: 589893 · Received April 6, 2005

    Report

    Report Number
    2029012-2005-00011
    Event Type
    Other
    Date Received
    April 6, 2005
    Date of Event
    January 10, 2005
    Report Date
    March 29, 2005
    Manufacturer
    INTERPORE CROSS INTL.
    Product Code
    JDK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    SURGEON REPORTED THAT THE IMPLANT CRACKED DURING SURGERY, HOWEVER THE IMPLANT DID NOT BREAK APART. NOTE: THE SURGEON OPTED TO LEAVE THE IMPLANT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPLEX C IMPLANT CEMENT RESTRICTOR JDK INTERPORE CROSS INTL. NA 405412

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other