BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELREPLACE CC NP 3.5X11.5MM

    MDR report key: 18917029 · Received March 15, 2024

    Report

    Report Number
    9611993-2024-053146
    Event Type
    Injury
    Date Received
    March 15, 2024
    Date of Event
    February 27, 2024
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    UDI-DI
    07332747160475
    PMA / PMN Number
    K062566
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE 15.03.2024 11:56:36 CET (5001035) IMPLANT FAILED DUE TO BONE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966645 NOBELREPLACE CC NP 3.5X11.5MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 12230712 07332747160475

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention