BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLANT 3.5D X 10L

    MDR report key: 24770284 · Received April 2, 2026

    Report

    Report Number
    9611993-2026-065924
    Event Type
    Injury
    Date Received
    April 2, 2026
    Manufacturer
    NOBEL BIOCARE AB GÖTEBORG
    Product Code
    DZE
    PMA / PMN Number
    K061319
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    03.02.2026 10:28:44 CET (5027901). 2026.01.28 00:23:28 CET (SEBACKGROUND). LOSS OF OSSEOINTEGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824793 REPLANT 3.5D X 10L ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB GÖTEBORG

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention