BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PTERYFIT IMPLANT

    MDR report key: 21751049 · Received April 2, 2025

    Report

    Report Number
    3012141159-2025-00195
    Event Type
    Injury
    Date Received
    April 2, 2025
    Date of Event
    March 18, 2025
    Report Date
    April 2, 2025
    Manufacturer
    NORIS MEDICAL LTD
    Product Code
    DZE
    UDI-DI
    07290108817102
    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 NMAF4218, LOT#9001420 IMPLANT LACKED PRIMARY STABILITY ON TOOTH #15 DUE TO LOW TORQUE, OSTEOTOMY DOESN'T MATCHTHE TYPE OR SIZE OF THE IMPLANT. THE IMPLANT WAS REMOVED DURING IMPLANT PLACEMENT WITH NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS. ACCORDING TO THE INFORMATION, THE PATIENT IS HEALTHY. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO OTHER MEDICAL ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2302634 PTERYFIT IMPLANT PTERYFIT DENTAL IMPLANT DZE NORIS MEDICAL LTD NMAF4218 9001420 07290108817102

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male