BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRA-CP

    MDR report key: 3850775 · Received March 21, 2014

    Report

    Report Number
    1223843-2014-00002
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    December 1, 2013
    Report Date
    March 21, 2014
    Manufacturer
    BICON, LLC
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A DENTIST IN THE USA EVALUATED THE CASE AND DETERMINED THAT OCCLUSION/OVERLOAD WAS THE ISSUE AND EXCESSIVE USE OF CEMENT WHICH LED TO SOME LOSS OF BONE LEADING TO THE IMPLANT BEING OVERLOADED.

    Description of Event or Problem · 1

    IMPLANT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170355 INTEGRA-CP DZE BICON, LLC 260-340-251 08894-0812B

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention