BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELREPLACE CC NP 3.5X11.5MM

    MDR report key: 16297523 · Received February 3, 2023

    Report

    Report Number
    2027971-2023-037366
    Event Type
    Injury
    Date Received
    February 3, 2023
    Date of Event
    January 24, 2022
    Report Date
    February 3, 2023
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    UDI-DI
    07332747160475
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NO
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO OSSEOINTEGRATION PROBLEM. 03.02.2023 12:09:17 CET (5012679). USER:5012679 RECEIVED DATE OF THE RETURN PRODUCT:03/02/2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1051646 NOBELREPLACE CC NP 3.5X11.5MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 36701 12180571 07332747160475

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Required Intervention