BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOUAREG OS DENTAL IMPLANT

    MDR report key: 19446060 · Received June 3, 2024

    Report

    Report Number
    3007518363-2024-00593
    Event Type
    Injury
    Date Received
    June 3, 2024
    Date of Event
    June 17, 2023
    Report Date
    May 10, 2024
    Manufacturer
    ADIN DENTAL IMPLANT SYSTEMS LTD
    Product Code
    DZE
    PMA / PMN Number
    K081751
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CLINICIAN REPORTED FAILURE OF TWO IMPLANTS DUE TO MOBILITY:ISF1342, LOT 7840714 AND ISF1350, LOT 7842701. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. MANUFACTURER'S TREND ANALYSIS SHOW THAT IMPLANT FAILURE IS A LOW-RATE ADVERSE EVENT, WHICH IS COMMON FOR ENDOSSEUS DENTAL IMPLANTS IN CLINICAL USE.

    Description of Event or Problem · 0

    DENTAL IMPLANT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1837622 TOUAREG OS DENTAL IMPLANT TOUAREG OS DENTAL IMPLANT DZE ADIN DENTAL IMPLANT SYSTEMS LTD ISF1342 7840714

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention