BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYGOMATIC IMPLANT

    MDR report key: 21738428 · Received April 1, 2025

    Report

    Report Number
    3012141159-2025-00190
    Event Type
    Injury
    Date Received
    April 1, 2025
    Date of Event
    March 5, 2025
    Report Date
    April 1, 2025
    Manufacturer
    NORIS MEDICAL LTD
    Product Code
    DZE
    UDI-DI
    07290108816488
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A HEALTHCARE PROFESSIONAL REPORTED THAT NM-F4432 LOT#0030625 IMPLANT LACKED PRIMARY STABILITY ON TOOTH #12 DUE TO BONE TOO SOFT. A SECONDARY IMPLANT WAS PLACED AFTER REMOVAL. THE IMPLANT WAS REMOVED DURING IMPLANT PLACEMENT WITH NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS. ACCORDING TO THE INFORMATION, THE PATIENT IS SMOKER, THE PATIENT HAS THYROID THERAPY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009675 ZYGOMATIC IMPLANT ZYGOMATIC DENTAL IMPLANT DZE NORIS MEDICAL LTD NM-F4432 0030625 07290108816488

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female