BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ¿ IMPLANT

    MDR report key: 18520469 · Received January 16, 2024

    Report

    Report Number
    9611993-2024-034870
    Event Type
    Injury
    Date Received
    January 16, 2024
    Date of Event
    December 21, 2023
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    PMA / PMN Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    FAILURE OSSEOINTEGRATE. 16.01.2024 16:03:16 CET (5001035) IMPLANT FAILED DUE TO FAILURE OF OSSEOINTEGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873104 UNKNOWN ¿ IMPLANT ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention