BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELREPLACE CC TIULTRA RP 4.3X10MM

    MDR report key: 17933611 · Received October 13, 2023

    Report

    Report Number
    2027971-2023-130887
    Event Type
    Injury
    Date Received
    October 13, 2023
    Date of Event
    October 11, 2023
    Report Date
    October 13, 2023
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    UDI-DI
    07332747128345
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE. 13.10.2023 16:13:42 CET (5021118). USER:5021118 RECEIVED DATE OF THE RETURN PRODUCT:13/10/2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683265 NOBELREPLACE CC TIULTRA RP 4.3X10MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 12219646 07332747128345

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention