BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT

    MDR report key: 22964796 · Received September 4, 2025

    Report

    Report Number
    3020652-2025-00011
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    January 25, 2023
    Report Date
    September 3, 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

    PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME IMPLANT. PATIENT IS DOING WELL.

    Description of Event or Problem · 0

    REP REPORTED THAT THE BEAR IMPLANT HYDRATED QUICKLY (< 20 SECONDS) AND INCONSISTENTLY. VISUALLY, THE DEVICE APPEARED HIGHLY VARIABLE FROM TOP (PROXIMAL) END OF IMPLANT TO THE BOTTOM (DISTAL) END. WHEN HYDRATED, BLOOD RAN THROUGH THE DEVICE AND WAS COMING OUT OF THE SUTURE HOLES. THE BOTTOM OF THE IMPLANT ALSO HYDRATED QUICKLY. DEVICE WAS VERY MALLEABLE IN THE ARTHROTOMY. THE DEVICE DID NOT HYDRATE CONSISTENTLY AND THE BOTTOM (DISTAL) END CAME OFF IN THE KNEE; HOWEVER, DR WAS ABLE TO PUSH THIS PORTION BACK ONTO THE IMPLANT PRIOR TO CLOSING THE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2081178 BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT Resorbable implant for anterior cruciate ligament (ACL) repair QNI MIACH ORTHOPAEDICS 7008409 00860002987804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown