BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9611993-2022-060337

    MDR report key: 14321541 · Received May 7, 2022

    Report

    Report Number
    9611993-2022-060337
    Event Type
    Injury
    Date Received
    May 7, 2022
    Date of Event
    April 18, 2022
    Manufacturer
    NOBEL BIOCARE (PRODUCTION) 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
    1632810 DZE NOBEL BIOCARE (PRODUCTION) AB

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention