BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOUAREG¿-S DENTAL IMPLANT 4.2D 10L

    MDR report key: 19557387 · Received June 18, 2024

    Report

    Report Number
    3007518363-2024-00646
    Event Type
    Injury
    Date Received
    June 18, 2024
    Date of Event
    May 22, 2024
    Report Date
    June 18, 2024
    Manufacturer
    ADIN DENTAL IMPLANT SYSTEMS LTD.
    Product Code
    DZE
    PMA / PMN Number
    K081751
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CLINICIAN REPORTED MULTIPLE IMPLANT FAILURES, CORRESPONDING TO DIFFERENT PATIENTS. NO FURTHER CLINICAL INFORMATION WAS SUPPLIED IN THIS COMPLAINT. THE CLINICIAN COMPLAINT INCLUDED THE FOLLOWING PRODUCTS: CAT# LOT. ISPS 1042, 7770421. ISPS 1042, 7785221. 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
    2337437 TOUAREG¿-S DENTAL IMPLANT 4.2D 10L TOUAREG¿-S DENTAL IMPLANT 4.2D 10L DZE ADIN DENTAL IMPLANT SYSTEMS LTD. ISPS1042 7770421

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention