BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL IMPLANT

    MDR report key: 24163907 · Received January 23, 2026

    Report

    Report Number
    3021188676-2026-00001
    Event Type
    Injury
    Date Received
    January 23, 2026
    Report Date
    December 14, 2025
    Manufacturer
    INFINITUM ETA LTD.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NOTIFICATION RECEIVED REGARDING THREE (3) ALLEGED IMPLANT FAILURES (LOSS OF OSSEOINTEGRATION) REPORTED BY THE SAME CLINICIAN. THE REPORTER INDICATES THAT ALL THREE INCIDENTS OCCURRED WITHIN THE FIRST THREE WEEKS OF TREATMENT FOLLOWING AN IMMEDIATE EXTRACTION AND IMMEDIATE PLACEMENT PROTOCOL. NO PERMANENT PATIENT INJURY OR ADDITIONAL MEDICAL INTERVENTION BEYOND THE EXPLANTATION WAS REPORTED. THE SPECIFIC DEVICE REF AND LOT NUMBERS ARE CURRENTLY BEING VERIFIED, AND A COMPLAINT INVESTIGATION WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225257 DENTAL IMPLANT DZE INFINITUM ETA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention