BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAGER & MEISINGER GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG

    MDR report key: 25148296 · Received May 12, 2026

    Report

    Report Number
    1287163-2026-20002
    Event Type
    Injury
    Date Received
    May 12, 2026
    Date of Event
    December 16, 2025
    Report Date
    January 15, 2026
    Manufacturer
    HAGER & MEISINGER GESELLSCHAFT MIT BESCHRÄNKTER
    Product Code
    DZE
    UDI-DI
    E0HMBLT5041121
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORT REQUIRED EXTENSIVE RESEARCH TO LOCATE THE PROPER MANUFACTURER OF THE DEVICE. THE DEVICE WAS SOLD UNDER A PRIVATE LABEL, ACE SURGICAL, TO WHOM IS NO LONGER IN OPERATIONS. AFTER THE SHUTDOWN, BIOHORIZONS RECEIVED THE DEVICE THROUGH A PARTNERSHIP TO FILE THE COMPLAINT RECORD. THE NEW ENTITY REQUIRED SETTTING UP IN THE COMPLAINT SYSTEM TO ALLOW FOR PROPER SUBMISSION.

    Description of Event or Problem · 0

    LOOSE IMPLANT TORN IN HALF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519555 HAGER & MEISINGER GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG DENTAL IMPLANT DZE HAGER & MEISINGER GESELLSCHAFT MIT BESCHRÄNKTER BLT504112 C25305 E0HMBLT5041121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention