BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT

    MDR report key: 22936889 · Received September 2, 2025

    Report

    Report Number
    3020652-2025-00004
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    March 7, 2023
    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

    PATIENT RECEIVED BEAR IMPLANT AND IS DOING FINE.

    Description of Event or Problem · 0

    DR. WAS DISAPPOINTED BY THE DENSITY OF THE BEAR. IT WAS TOO DENSE AND DID NOT SEEM TO HAVE A POROUS SIDE. THIS HAPPENED WITH TWO OF THE IMPLANTS USED ON (B)(6) 2023. HOWEVER, THESE WERE OF THE SAME LOT AS THE ONE USED ON (B)(6) 2023. HE IS CONCERNED ABOUT THE VARIABILITY BETWEEN IMPLANTS OF THE SAME LOT AND DOES NOT LIKE THE DIFFICULTY HE HAD HYDRATING IT. THIS IS THE FIRST TIME HE HAS HAD TO USE THE BLUNT TIPPED NEEDLE TO PROPERLY HYDRATE THE BEAR. DR. SPECIFICALLY TOLD ME TO MAKE A NOTE OF IT AND DID WAS NOT THRILLED BY THE SITUATION. PATIENT RECEIVED BEAR IMPLANT AND IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2074559 BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT Resorbable implant for anterior cruciate ligament (ACL) repair QNI MIACH ORTHOPAEDICS 7009195 00860002987804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown