BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0001222315-2025-002597

    MDR report key: 23054089 · Received September 15, 2025

    Report

    Report Number
    0001222315-2025-002597
    Event Type
    Injury
    Date Received
    September 15, 2025
    Date of Event
    August 6, 2025
    Report Date
    September 15, 2025
    Manufacturer
    STRAUMANN MANUFACTURING, INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NV, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2025 IN ADA 13. ON (B)(6) 2025, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1720703 DZE STRAUMANN MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention