BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELREPLACE CC PMC NP 3.5X11.5MM

    MDR report key: 18916879 · Received March 15, 2024

    Report

    Report Number
    2027971-2024-056557
    Event Type
    Injury
    Date Received
    March 15, 2024
    Date of Event
    February 13, 2024
    Report Date
    March 15, 2024
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AU
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE 15.03.2024 13:33:16 CET (5001035) IMPLANT FAILED DUE TO ABCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966599 NOBELREPLACE CC PMC NP 3.5X11.5MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention