BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2027971-2022-043439

    MDR report key: 13572167 · Received February 21, 2022

    Report

    Report Number
    2027971-2022-043439
    Event Type
    Injury
    Date Received
    February 21, 2022
    Date of Event
    September 22, 2021
    Report Date
    February 21, 2022
    Manufacturer
    NOBEL BIOCARE USA, LLC
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor 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
    1079758 DZE NOBEL BIOCARE USA, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention