BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELREPLACE CC PMC NP 3.5X11.5MM

    MDR report key: 19778217 · Received July 18, 2024

    Report

    Report Number
    9611993-2024-091964
    Event Type
    Injury
    Date Received
    July 18, 2024
    Date of Event
    February 20, 2024
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    PMA / PMN Number
    K073142
    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2032119 NOBELREPLACE CC PMC NP 3.5X11.5MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention