BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT

    MDR report key: 22964802 · Received September 4, 2025

    Report

    Report Number
    3020652-2025-00017
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    August 1, 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 SAME DEVICE. PATIENT IS DOING WELL.

    Description of Event or Problem · 0

    THE IMPLANT HYDRATED VERY QUICKLY WITH ONLY 5 CC OF BLOOD APPLIED, AT WHICH POINT THE DEVICE FELL OFF THE INTERNAL BRACE SUTURES PRIOR TO IMPLANTATION. THE DEVICE REMAINED IN THE SURGEON'S HAND, SO HE IMPLANTED THE DEVICE, BUT IT WAS NOT LOADED ON THE SUTURES. HE THEN BACKFILLED WITH 5 CC OF BLOOD. THE TOTAL TIME FROM THE FIRST DROP OF BLOOD UNTIL THE IMPLANT FELL OFF THE SUTURES WAS APPROXIMATELY 1:30. IN MY OPINION AND IN SPEAKING TO THE DR ABOUT THE CASE AFTERWARDS, HE PROBABLY OVERMANIPULATED THE IMPLANT AND RUSHED TO HYDRATE WITH BLOOD (HE WAS BULLETING THE TIP AND MASSAGING THE SIDES). HOWEVER, HE COULD NOT HAVE IMPLANTED THE DEVICE SOONER BECAUSE HE WAS STILL WORKING BLOOD INTO THE DEVICE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH SAME DEVICE. PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2082134 BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT Resorbable implant for anterior cruciate ligament (ACL) repair QNI MIACH ORTHOPAEDICS 7009359 00860002987804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown