BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELACTIVE INTERNAL RP 4.3X11.5MM

    MDR report key: 20571708 · Received October 30, 2024

    Report

    Report Number
    9611993-2024-120801
    Event Type
    Injury
    Date Received
    October 30, 2024
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    UDI-DI
    07332747160079
    PMA / PMN Number
    K071370
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO IMPLANT FRACTURE AT/AFTER DELIVERY. (B)(6) 2024 15:34:51 CET (5020889) IMPLANT FAILED DUE TO IMPLANT FRACTURE AT/AFTER DELIVERY OF PROSTHETIC RESTORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2065778 NOBELACTIVE INTERNAL RP 4.3X11.5MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 12104396 07332747160079

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention