BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PTERYFIT IMPLANT

    MDR report key: 19444639 · Received June 2, 2024

    Report

    Report Number
    3011390931-2024-00249
    Event Type
    Injury
    Date Received
    June 2, 2024
    Date of Event
    February 21, 2024
    Report Date
    June 2, 2024
    Manufacturer
    NORIS MEDICAL LTD
    Product Code
    DZE
    UDI-DI
    07290108817133
    PMA / PMN Number
    K140440
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PROBABILITY OF A MANUFACTURING OR DESIGN DEFECT THAT MIGHT LEAD TO IMPLANT REPLACEMENT DUE TO A PATIENT'S ANATOMICAL DEFECT HAS BEEN NONEXISTENT. IF ADDITIONAL INFORMATION IS RECEIVED THAT INDICATES THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY.

    Description of Event or Problem · 0

    THE HEALTHCARE PROFESSIONAL REPORTS THAT THE NMAF4225 LOT# 9000649 IMPLANT WAS INSERTED IN THE PATIENT'S MOUTH IN (B)(6) 2024. THE IMPLANT WAS REMOVED DURING PLACEMENT DUE TO PTERYGOID SOFT BONE. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. NO PATIENT-OPERATIVE OR POST-OPERATIVE COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2124480 PTERYFIT IMPLANT PTERYFIT DENTAL IMPLANT DZE NORIS MEDICAL LTD NMAF4225 9000649 07290108817133

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown