BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONYX IMPLANT

    MDR report key: 17867919 · Received October 4, 2023

    Report

    Report Number
    3011390931-2023-00002
    Event Type
    Malfunction
    Date Received
    October 4, 2023
    Date of Event
    May 28, 2023
    Report Date
    October 4, 2023
    Manufacturer
    NORIS MEDICAL LTD
    Product Code
    DZE
    UDI-DI
    07290108813104
    PMA / PMN Number
    K140440
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOWING A THOROUGH INVESTIGATION INTO THE COMPLAINT, NO PRODUCT DEFICIENCIES OR MANUFACTURING PROCESS DEVIATIONS HAVE BEEN DETECTED. WE DILIGENTLY ATTEMPTED TO ESTABLISH COMMUNICATION WITH THE DENTIST. WHILE THE DENTIST DID PROVIDE SOME INFORMATION, CRUCIALLY, THEY HAVE NOT FURNISHED THE LOT NUMBERS FOR THE PROSTHETIC PARTS OR PHOTOGRAPHS OF THE RESTORATION IN ITS INTRAORAL CONTEXT. CONSEQUENTLY, WE ARE UNABLE TO ARRIVE AT A DEFINITIVE CONCLUSION REGARDING THE UNDERLYING CAUSE OF THE ISSUE. SHOULD NEW OR ADDITIONAL INFORMATION BECOME AVAILABLE DURING THE COURSE OF THIS INVESTIGATION, WE WILL PROVIDE A FOLLOW-UP REPORT ACCORDINGLY. WE MISTAKENLY SENT THE ANSWER FOR THIS COMPLAINT ON 21 JUNE 2023 TO THE TEST SYSTEM INSTEAD OF THE PRODUCTION ACCOUNT. HENCE, THE LATE REPORTING. WE ATTACHED THE APPROVAL THAT WE SENT THE REPORT TO THE TEST SYSTEM. WE IMPROVED OUR REPORTING PROCESS TO AVOID RECURRENCE OF SUCH MISTAKE.

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY.

    Description of Event or Problem · 0

    FOLLOWING A PATIENT'S COMPLAINT AND AFTER AN EXAMINATION, DOCTOR REPORTED A FRACTURE IN 3 IMPLANTS. THIS REPORT IS 1 OF 3 RELATED TO THIS EVENT, AND 2 MORE REPORTS ARE ISSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1526295 ONYX IMPLANT ONYX DENTAL IMPLANT DZE NORIS MEDICAL LTD NM-G3713 0021287 07290108813104

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female