BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELACTIVE INTERNAL NP 3.5X11.5MM

    MDR report key: 10403685 · Received August 13, 2020

    Report

    Report Number
    9611993-2020-32833
    Event Type
    Injury
    Date Received
    August 13, 2020
    Date of Event
    February 4, 2020
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    UDI-DI
    7332747010596
    PMA / PMN Number
    K071370
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PMN K071370, LST D080086, PROD CODE 76DZE, DEV 9611993.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865201 NOBELACTIVE INTERNAL NP 3.5X11.5MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 12142614 7332747010596

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention