BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIN IMPLANTE

    MDR report key: 25281005 · Received May 26, 2026

    Report

    Report Number
    1060818-2026-80008
    Event Type
    Injury
    Date Received
    May 26, 2026
    Date of Event
    April 16, 2026
    Report Date
    May 16, 2026
    Manufacturer
    SIN SISTEMA DE IMPLANTE NACIONAL S/A
    Product Code
    DZE
    UDI-DI
    07899995271921
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CI
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THESE RECORDS ARE BEING SUBMITTED FOLLOWING THE COMPLETION OF THE NECESSARY SYSTEM UPDATES TO CORRECTLY REFLECT THE PROPER MANUFACTURER INFORMATION WITHIN SECTION D. CONFIGURATION AND VALIDATION DOCUMENTATION UPDATES WERE REQUIRED TO ENABLE SUBMISSION OF THE MANUFACTURER, SIN SISTEMA DE IMPLANTE NACIONAL S/A, WITHIN SECTION D AND F ALONG WITH THE CONTACT OFFICE INFORMATION FOR BIOHORIZONS WITHIN SECTION F. THE UPDATES SUPPORTED THE PROPER HANDLING FOR FUTURE SUBMISSIONS. THE RECORDS INCLUDED IN THIS SUBMISSION REFLECT THE ORIGINALLY REPORTED DEVICES PROVIDED TO BIOHORIZONS.

    Description of Event or Problem · 0

    IMPLANT FAILED TO OSSEOINTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425916 SIN IMPLANTE DENTAL IMPLANT DZE SIN SISTEMA DE IMPLANTE NACIONAL S/A SWCM 3810N W100458709 07899995271921

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention