BEUDAMED
    FDA Adverse Event Injury Summary report: N

    0001222315-2023-000788

    MDR report key: 16149411 · Received January 12, 2023

    Report

    Report Number
    0001222315-2023-000788
    Event Type
    Injury
    Date Received
    January 12, 2023
    Date of Event
    December 12, 2022
    Report Date
    January 12, 2023
    Manufacturer
    STRAUMANN MANUFACTURING, INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2022 IN ADA 10. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2022, 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. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536106 DZE STRAUMANN MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention