BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERA IMPLANT SYSTEM

    MDR report key: 24277827 · Received February 6, 2026

    Report

    Report Number
    3011386779-2025-00256
    Event Type
    Malfunction
    Date Received
    February 6, 2026
    Date of Event
    December 15, 2025
    Report Date
    March 12, 2026
    Manufacturer
    INTEGRUM AB
    Product Code
    PJY
    UDI-DI
    07340152100634
    PMA / PMN Number
    P190009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    2026-01-07: INTEGRUM WAS INFORMED THAT AXOR II UNIT (B)(6) HAS FALLEN OFF FROM THE ABUTMENT. NO INJURY REPORTED. THE UNIT HAS NOT YET BEEN RECEIVED, HENCE NO TECHNICAL INVESTIGATION PERFORMED.

    Description of Event or Problem · 0

    2026-01-07: INTEGRUM WAS INFORMED THAT AXOR II UNIT (B)(6) HAS FALLEN OFF FROM THE ABUTMENT. NO INJURY REPORTED. MANUFACTURING INVESTIGATION PERFORMED; NO DEVIATIONS WERE FOUND. 2026-02-24: TECHNICAL INVESTIGATION OF UNIT (B)(6) PERFORMED. DURING THE INVESTIGATION THE REPORTED ISSUE COULD BE REPLICATED; THE TOP SPRING WAS TANGLED AND WORN CAUSING INSUFFICIENT GRIP. DURING THE SERVICE THE DEVICE WAS THOROUGHLY CLEANED, THE TOP SPRING WAS REPLACED AND THE UNIT WAS FUNCTIONALLY TESTED ACCORDING TO SPECIFICATION WITH APPROVED RESULTS. A FEEDBACK REPORT WILL BE PROVIDED TO THE CUSTOMER HIGHLIGHTING THE IMPORTANCE OF DONNING THE AXOR II ACCORDING TO THE IFU AND THAT THE AXOR SHALL NOT BE USED IF A STABLE CONNECTION CANNOT BE ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278223 OPERA IMPLANT SYSTEM AXOR II PJY INTEGRUM AB 1288 58777 07340152100634

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other