BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRA-CP

    MDR report key: 7817803 · Received August 27, 2018

    Report

    Report Number
    1223843-2018-00003
    Event Type
    Injury
    Date Received
    August 27, 2018
    Date of Event
    July 18, 2018
    Report Date
    August 27, 2018
    Manufacturer
    BICON, LLC
    Product Code
    DZE
    PMA / PMN Number
    K101849
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE DENTIST, THE FIRST STAGE WAS DONE WITHOUT PROBLEMS. AT THE SECOND STAGE AND PLACEMENT OF THE HEALING ABUTMENT, NO PROBLEM WAS DETECTED. BUT A FEW DAYS AFTER, THE PATIENT PRESENTED WITH INFLAMMATION AROUND THE IMPLANT WITH INTENSE PAIN. THE DENTIST REMOVED THE HEALING ABUTMENT AND CLEANED THE WELL OF THE IMPLANT AND FOUND THE FLOOR OF THE IMPLANT WAS PERFORATED. THE DENTIST DECIDED FOR THE EXPLANTATION OF THE IMPLANT, GBR, AND TO PLACE ANOTHER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660439 INTEGRA-CP DENTAL IMPLANT DZE BICON, LLC 260-350-305 100880817B

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention