BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPRA IMPLANT SYSTEM

    MDR report key: 21699166 · Received March 26, 2025

    Report

    Report Number
    3011386779-2025-00226
    Event Type
    Malfunction
    Date Received
    March 26, 2025
    Date of Event
    January 14, 2025
    Report Date
    March 27, 2025
    Manufacturer
    INTEGRUM AB
    Product Code
    PJY
    UDI-DI
    07340152100634
    PMA / PMN Number
    P190009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    2025-03-27: CORRECTIONS MADE TO H. DEVICE MANUFACTURERS ONLY, 6. ADVERSE EVENT PROBLEM: CHANGED CODE (E) AND (F) DUE TO NO HEALTH CONSEQUENCES OR PATIENT INJURY HAS BEEN REPORTED. ADDED TYPE OF INVESTIGATION CODE (10) AND (4111).

    Description of Event or Problem · 0

    2025-03-05: INTEGRUM HAS BEEN INFORMED THAT AXOR II UNIT (B)(6) HAS FALLEN OFF FROM THE ABUTMENT. MANUFACTURING INVESTIGATION PERFORMED; BATCH DOCUMENTATION REVIEWED. NO DEVIATIONS FOUND; THE DEVICE HAS BEEN MANUFACTURED ACCORDING TO SPECIFICATION. 2025-03-18. TECHNICAL INVESTIGATION OF UNIT (B)(6) PERFORMED. DURING THE INVESTIGATION THE DEVICE FUNCTIONS WERE TESTED AND COMPONENTS INSPECTED. THE REPORTED ISSUE COULD NOT BE REPLICATED. THE CLAMPS WERE SHOWING SIGNS OF WEAR INDICATING THAT THE ABUTMENT MAY HAVE NOT BEEN FULLY INSERTED AT SOME POINT. DURING THE SERVICE THE DEVICE WAS THOROUGHLY CLEANED AND DAMAGED COMPONENTS WERE REPLACED. FINALLY, THE DEVICE WAS FUNCTIONALLY TESTED WITH APPROVED RESULTS. INTEGRUM HAS INFORMED THE CLINIC ON THE IMPORTANCE OF DONNING THE AXOR II ACCORDING TO THE IFU TO ENSURE A STABLE CONNECTION AND PREVENT DAMAGE OR WEAR TO THE CLAMPS. AS STATED IN THE IFU, THE DEVICE SHALL NOT BE USED IF A STABLE CONNECTION CANNOT BE ACHIEVED.

    Description of Event or Problem · 0

    ON 2025-03-05: INTEGRUM HAS BEEN INFORMED THAT AXOR II UNIT (B)(6) HAS FALLEN OFF FROM THE ABUTMENT. MANUFACTURING INVESTIGATION PERFORMED, BATCH DOCUMENTATION REVIEWED. NO DEVIATIONS FOUND, THE DEVICE HAS BEEN MANUFACTURED ACCORDING TO SPECIFICATION. ON 2025-03-18. TECHNICAL INVESTIGATION OF UNIT (B)(6) PERFORMED. DURING THE INVESTIGATION THE DEVICE FUNCTIONS WERE TESTED AND COMPONENTS INSPECTED. THE REPORTED ISSUE COULD NOT BE REPLICADED. THE CLAMPS WERE SHOWING SIGNS OF WEAR INDICATING THAT THE ABUTMENT MAY NOT HAVE BEEN FULLY INSERTED AT SOME POINT. DURING THE SERVICE THE DEVICE WAS THOROUGHLY CLEANED AND DAMAGED COMPONENTS WERE REPLACED. FINALLY, THE DEVICE WAS FUNCTIONALLY TESTED WITH APPROVED RESULTS. INTEGRUM HAS INFORMED THE CLINIC ON THE IMPORTANCE OF DONNING THE AXOR II ACCORDING TO THE IFU TO ENSURE A STABLE CONNECTION AND PREVENT DAMAGE OR WEAR TO THE CLAMPS. AS STATED IN THE IFU, THE DEVICE SHALL NOT BE USED IF A STABLE CONNECTION CANNOT BE ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1719589 OPRA IMPLANT SYSTEM AXOR II PJY INTEGRUM AB 1288 55711 07340152100634

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other