BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSSEOUS DENTAL IMPLANT

    MDR report key: 15086520 · Received July 22, 2022

    Report

    Report Number
    0001222315-2022-15519
    Event Type
    Injury
    Date Received
    July 22, 2022
    Date of Event
    April 7, 2022
    Report Date
    July 22, 2022
    Manufacturer
    STRAUMANN MANUFACTURING, INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REPORT REJECTED TO SEEK GUIDANCE FOR MISSING DEVICE INFORMATION. LW (B)(6) 2022. THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2021 IN ADA 30. DETAILS OF SURGERY: IMPLANT SURFACE NOT COMPLETELY COVERED WITH BONE. ON (B)(6) 2022, LOSS OF OSSEOINTEGRATION WAS VERIFIED. PATIENT PRESENTED WITH FAIR ORAL HYGIENE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. AT THE EVENT THE PATIENT EXPERIENCED: INFECTION AND FISTULA. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570002 ENDOSSEOUS DENTAL IMPLANT ENDOSSEOUS DENTAL IMPLANT DZE STRAUMANN MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention