BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELREPLACE CC PMC NP 3.5X11.5MM

    MDR report key: 20205076 · Received September 12, 2024

    Report

    Report Number
    9611993-2024-107303
    Event Type
    Injury
    Date Received
    September 12, 2024
    Date of Event
    August 20, 2024
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    PMA / PMN Number
    K073142
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED, DUE TO A FAILURE TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557367 NOBELREPLACE CC PMC NP 3.5X11.5MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Required Intervention