BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT

    MDR report key: 22936922 · Received September 2, 2025

    Report

    Report Number
    3020652-2025-00005
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    April 12, 2024
    Report Date
    September 2, 2025
    Manufacturer
    MIACH ORTHOPAEDICS
    Product Code
    QNI
    UDI-DI
    00860002987804
    PMA / PMN Number
    K243578
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CASE WAS COMPLETED SUCCESSFULLY WITH THE IMPLANT. PATIENT IS DOING WELL.

    Description of Event or Problem · 0

    IMPLANT HYDRATED EXTREMELY SLOW. TOOK 20 CC AND MAYBE 5 MIN. MUCH MUCH MUCH SLOWER THAN AVERAGE HYDRATION. COULD TELL THE IMPLANT WAS VERY DENSE WHEN SURGEON SLID KEITH NEEDLE INTO IT. SURGEON USED A SYRINGE MULTIPLE TIMES TO INJECT BLOOD INTO THE CORE OF THE IMPLANT. WE WERE STILL ABLE TO USE IT AND IT SOFTENED UP AFTER ABOUT FIVE MINUTES OF HYDRATING WHEN THE IMPLANT WAS ALREADY IN THE KNEE. THE CASE WAS COMPLETED SUCCESSFULLY WITH THE IMPLANT. PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240573 BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT Resorbable implant for anterior cruciate ligament (ACL) repair QNI MIACH ORTHOPAEDICS 7009361 00860002987804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown