BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0001222315-2025-002709

    MDR report key: 23169642 · Received September 29, 2025

    Report

    Report Number
    0001222315-2025-002709
    Event Type
    Injury
    Date Received
    September 29, 2025
    Date of Event
    August 27, 2025
    Report Date
    September 29, 2025
    Manufacturer
    STRAUMANN MANUFACTURING, INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, 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 20. DETAILS OF SURGERY: PRIMARY STABILITY NOT ACHIEVED AND IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2025, NON-OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH BONE TYPE III, FAIR ORAL HYGIENE AND INADEQUATE BONE QUALITY/QUANTITY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION, PERI-IMPLANTITIS, PAIN AND FISTULA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1945627 DZE STRAUMANN MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention