BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT

    MDR report key: 22965575 · Received September 4, 2025

    Report

    Report Number
    3020652-2025-00018
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    January 11, 2024
    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

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

    Description of Event or Problem · 0

    THE BEAR IMPLANT DID NOT HYDRATE PROPERLY AND IN FACT, NOT REALLY AT ALL. WE HYDRATED THE DEVICE WITH 15CC WHOLE BLOOD, THEN LET THE TOURNIQUET DOWN TO FILL UP THE SPECIMEN CUP WITH ANOTHER 20+ CC OF BLOOD. AFTER ABOUT 5 MINUTES OF WAITING FOR THE IMPLANT TO HYDRATE, DR. ATTEMPTED TO PASS THE DEVICE THROUGH THE ARTHROTOMY AND THE IMPLANT BROKE IN HALF VERTICALLY. HE TOOK ONE OF THE HALVES AND SUBMERGED IT IN THE SPECIMEN CUP OF BLOOD AND IT STILL DIDN'T GET ANY SOFTER. WE OPENED A SECOND IMPLANT FROM A DIFFERENT LOT, AND IT HYDRATED IMMEDIATELY SO WE WERE ABLE TO FINISH THE PROCEDURE, BUT DR. SAID THAT WHAT WAS LEFT OF THE FIRST IMPLANT WAS STILL VERY FIRM INSIDE THE KNEE WHEN HE CLOSED (THE KNEE). PROCEDURE WAS COMPLETED SUCCESSFULLY WITH SECOND IMPLANT. PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1675791 BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT Resorbable implant for anterior cruciate ligament (ACL) repair QNI MIACH ORTHOPAEDICS 7009362 00860002987804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown