BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL IMPLANT

    MDR report key: 24545076 · Received March 9, 2026

    Report

    Report Number
    MW5184855
    Event Type
    Malfunction
    Date Received
    March 9, 2026
    Date of Event
    October 15, 2025
    Report Date
    February 20, 2026
    Manufacturer
    BIOHORIZONS IMPLANT SYSTEMS INC.
    Product Code
    DZE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PLEASE MARK DETERMINATION OF THE PRINCIPAL REASON FOR REMOVAL: IMPLANT LOADING. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614535 DENTAL IMPLANT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE BIOHORIZONS IMPLANT SYSTEMS INC. 2404914

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown