BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPRA IMPLANT SYSTEM

    MDR report key: 21331122 · Received February 7, 2025

    Report

    Report Number
    3011386779-2025-00217
    Event Type
    Injury
    Date Received
    February 7, 2025
    Date of Event
    January 8, 2025
    Report Date
    February 7, 2025
    Manufacturer
    INTEGRUM
    Product Code
    PJY
    PMA / PMN Number
    P190009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SURGERY FOR FIXTURE REMOVAL FROM TIBIA DUE TO LACK OR LOSS OF OSSEOINTEGRATION. NO CLINICAL SIGNS WERE REPORTED. THE PROCEDURE TOOK PLACE IN (B)(6) ON (B)(6) 2025. THE MOST PROBABLE ROOT CAUSES ARE LACK OR LOSS OF OSSEOINTEGRATION AND OFF-LABEL USE.

    Description of Event or Problem · 0

    SURGERY FOR FIXTURE REMOVAL FROM TIBIA DUE TO LACK OR LOSS OF OSSEOINTEGRATION. NO CLINICAL SIGNS WERE REPORTED. THE PROCEDURE TOOK PLACE IN OSLO, NORWAY ON J(B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1532487 OPRA IMPLANT SYSTEM FIXTURE BIOHELIX 19,5X80 PJY INTEGRUM 1807 6090

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other