BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELACTIVE INTERNAL NP 3.5X13MM

    MDR report key: 20499980 · Received October 21, 2024

    Report

    Report Number
    2027971-2024-136324
    Event Type
    Injury
    Date Received
    October 21, 2024
    Date of Event
    August 21, 2024
    Manufacturer
    NOBEL BIOCARE USA INC
    Product Code
    DZE
    UDI-DI
    07332747160048
    PMA / PMN Number
    K071370
    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 PART NOF FITTING/ALIGNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249408 NOBELACTIVE INTERNAL NP 3.5X13MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE USA INC 13170340 07332747160048

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention