BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN INTERNAL HEX. IMPLANT DIA. 4.20 L 11.50MM

    MDR report key: 21393839 · Received February 18, 2025

    Report

    Report Number
    3004203816-2025-09606
    Event Type
    Injury
    Date Received
    February 18, 2025
    Report Date
    February 18, 2025
    Manufacturer
    MIS IMPLANTS TECHNOLOGIES LTD.
    Product Code
    DZE
    UDI-DI
    07290108998344
    PMA / PMN Number
    K180282
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    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. THIS MDR REPORT IS A LATE SUBMISSION. A CAPA (NCR2405716) HAS BEEN ISSUED.

    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
    1168375 SEVEN INTERNAL HEX. IMPLANT DIA. 4.20 L 11.50MM IMPLANT, ENDOSSEOUS, ROOT-FORM DZE MIS IMPLANTS TECHNOLOGIES LTD. W16010482 07290108998344

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention