BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN XD INT. HEX. IMPLANT D3.75 L8MM SP

    MDR report key: 21305016 · Received February 4, 2025

    Report

    Report Number
    3004203816-2025-06073
    Event Type
    Injury
    Date Received
    February 4, 2025
    Report Date
    February 4, 2025
    Manufacturer
    MIS IMPLANTS TECHNOLOGIES LTD.
    Product Code
    DEZ
    UDI-DI
    07290113997684
    PMA / PMN Number
    K180282
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS NOT EVALUATED BECAUSE THE ISSUE IS A KNOWN INHERENT RISK OF THE DEVICE. WE WILL CONTINUE TO TRACK AND MONITOR THE TREND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258845 SEVEN XD INT. HEX. IMPLANT D3.75 L8MM SP IGM, RHODAMINE, ANTIGEN, ANTISERUM, CONTROL DEZ MIS IMPLANTS TECHNOLOGIES LTD. N/A W22014690 07290113997684

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention