BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT

    MDR report key: 22964133 · Received September 4, 2025

    Report

    Report Number
    3020652-2025-00009
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    December 15, 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
    1675703 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