BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT

    MDR report key: 22964801 · Received September 4, 2025

    Report

    Report Number
    3020652-2025-00016
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    June 23, 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 SECOND IMPLANT. PATIENT IS DOING WELL.

    Description of Event or Problem · 0

    THE FIRST IMPLANT WE UTILIZED ALMOST IMMEDIATELY HYDRATED AND THE SURGEON'S FINGER WENT THROUGH THE AXIS OF THE IMPLANT WHEN PUSHING INTO THE NOTCH AND COULD NOT BE IMPLANTED. QUICK HYDRATION CAUGHT US ALL OFF GUARD. CASE WAS COMPLETED SUCCESSFULLY WITH A SECOND DEVICE (LOT 7009359).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2082133 BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT Resorbable implant for anterior cruciate ligament (ACL) repair QNI MIACH ORTHOPAEDICS 7009197 00860002987804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown