BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2027971-2022-041535

    MDR report key: 13537276 · Received February 15, 2022

    Report

    Report Number
    2027971-2022-041535
    Event Type
    Injury
    Date Received
    February 15, 2022
    Date of Event
    January 31, 2022
    Manufacturer
    NOBEL BIOCARE USA, LLC
    Product Code
    DZE
    PMA / PMN Number
    K083205
    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 FAILURE OF OSSEOINTEGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1733871 DZE NOBEL BIOCARE USA, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention