BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT

    MDR report key: 22965576 · Received September 4, 2025

    Report

    Report Number
    3020652-2025-00019
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    February 6, 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 THE IMPLANT. PATIENT IS DOING WELL.

    Description of Event or Problem · 0

    THE BEAR IMPLANT HAD ALMOST NO GRADIENT AND IT WAS VERY DIFFICULT TO TELL WHICH SIDE WAS DENSER. THE IMPLANT DID NOT WANT TO HYDRATE. I'VE SEEN OVER 200 BEAR IMPLANTS GO IN, AND DOCTOR HAS DONE 25, SO I'M GOING TO SUGGEST NO USER ERROR HERE. HE USED 15 CC OF BLOOD, AND THE CORE WAS STILL ROCK HARD, ADDITIONALLY, UPON IMPLANTING, A FEW CHUNKS BROKE OFF FROM THE DISTAL END. I ASKED HIM AT THE END OF THE CASE HOW IT FELT, AND HE SAID WHAT WAS IN THE NOTCH WAS GOOD. THE CASE WAS COMPLETED SUCCESSFULLY WITH THE IMPLANT. PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1675792 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