BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9611993-2023-083278

    MDR report key: 17244252 · Received July 1, 2023

    Report

    Report Number
    9611993-2023-083278
    Event Type
    Injury
    Date Received
    July 1, 2023
    Date of Event
    June 6, 2023
    Manufacturer
    NOBEL BIOCARE (PRODUCTION) AB
    Product Code
    DZE
    PMA / PMN Number
    K062566
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED BECAUSE PRIMARY STABILITY COULD NOT BE ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207772 DZE NOBEL BIOCARE (PRODUCTION) AB

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention