BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPRA IMPLANT SYSTEM

    MDR report key: 18290107 · Received December 8, 2023

    Report

    Report Number
    3011386779-2023-00136
    Event Type
    Malfunction
    Date Received
    December 8, 2023
    Report Date
    December 8, 2023
    Manufacturer
    INTEGRUM AB
    Product Code
    PJY
    UDI-DI
    07340152100634
    PMA / PMN Number
    P190009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    2023-11-10: INTEGRUM RECEIVED UNIT I6486 WITH A REPORT FORM STATING THAT THE AXOR II FELL OFF FROM THE ABUTMENT. THE EXACT DATE OF EVENT IS UNKNOWN. NO FALL OR HEALTH CONSEQUENCES. 2023-11-16: TECHNICAL INVESTIGATION OF UNIT I6486 PERFORMED. DURING THE INVESTIGATION, IT WAS NOTED THAT THE CLAMPS WERE PLACED IN AN INCORRECT SEQUENCE AND THAT THE TOP SPRING WAS MISALIGNED. HOWEVER, THE ATTACHMENT ISSUE COULD NOT BE REPLICATED DURING TESTING. MANUFACTURING INVESTIGATION PERFORMED, BATCH DOCUMENTATION DOCREG 010 958-00 REVIEWED; NO DEVIATIONS WERE FOUND - THE CLAMP SEQUENCE AND TOP SPRING WERE ACCORDING TO SPECIFICATION WHEN RELEASED FROM INTEGRUM. THE UNIT HAS NOT BEEN SENT TO INTEGRUM FOR ANNUAL SERVICE (SINCE ITS INITIAL RELASE FROM INTEGRUM 2021-02-04) ACCORDING TO INSTRUCTIONS IN THE IFU. DURING THE SERVICE, THE CLAMPS WERE PLACED IN THE CORRECT SEQUENCE AND THE TOP SPRING WAS RE-ALIGNED. THE DEVICE WAS FUNCTIONALLY TESTED ACCORDING TO SPECIFICATION WITH APPROVED RESULTS. A FEEDBACK REPORT WILL BE PROVIDED TO THE CUSTOMER HIGHLIGHTING THE IMPORTANCE OF FOLLOWING THE AXOR II TOP COMPONENT INSPECTION INSTRUCTION DURING CLEANING AND ASSEMBLY OF THE AXOR II, AND SENDING THE AXOR II FOR ANNUAL SERVICE ACCORDING TO THE IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258848 OPRA IMPLANT SYSTEM AXOR II PJY INTEGRUM AB 1288 53272 07340152100634

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other