BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT

    MDR report key: 22964131 · Received September 4, 2025

    Report

    Report Number
    3020652-2025-00010
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    December 28, 2022
    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

    WHEN OPENED FROM POUCH, IT WAS DIFFICULT TO DISCERN TOP OF IMPLANT FROM BOTTOM (BASE). BEAR IMPLANT HYDRATED VERY FAST AND FELL APART WHEN ATTEMPTING TO PUT IN KNEE. IMPLANT WAS DISCARDED AND PROCEDURE WAS COMPLETED WITH A SECOND IMPLANT. SECOND IMPLANT LOOKED BETTER AND HYDRATED NORMALLY AND WAS FROM THE SAME LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1675701 BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT Resorbable implant for anterior cruciate ligament (ACL) repair QNI MIACH ORTHOPAEDICS 7008409 00860002987804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown