BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL IMPLANT

    MDR report key: 24854801 · Received April 13, 2026

    Report

    Report Number
    MW5186675
    Event Type
    Injury
    Date Received
    April 13, 2026
    Report Date
    April 7, 2026
    Manufacturer
    BIOHORIZONS IMPLANT SYSTEMS INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PLEASE FIND ATTACHED ADVERSE EVENT INFORMATION ABOUT A DEVICE THAT WAS NOT MANUFACTURED OR IMPORTED BY (B)(6). THIS REPORT IS BEING FORWARDED TO FDA IN ACCORDANCE WITH 21 CFR 803.22 (B) (2), BECAUSE NO COMPANY WITHIN (B)(6) IS THE MANUFACTURER OR IMPORTER OF THE DEVICE. THE DEVICE AND INFORMATION ARE BEING RETURNED BY (B)(6) TO THE REPORTING COMPLAINANT. PAIN, MOBILITY. INFLAMMATION. THIS REPORT REFLECTS INFO 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
    537444 DENTAL IMPLANT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE BIOHORIZONS IMPLANT SYSTEMS INC. 2002090

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male