BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELREPLACE CC TIULTRA RP 4.3X8MM

    MDR report key: 17365724 · Received July 20, 2023

    Report

    Report Number
    9611993-2023-088658
    Event Type
    Injury
    Date Received
    July 20, 2023
    Date of Event
    July 6, 2023
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    UDI-DI
    07332747128321
    PMA / PMN Number
    K202344
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO BEING PARTIALLY VISIBLE. PATIENT STRESS AND INFECTION WERE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36066 NOBELREPLACE CC TIULTRA RP 4.3X8MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 300342 12215772 07332747128321

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention