BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT

    MDR report key: 22964747 · Received September 4, 2025

    Report

    Report Number
    3020652-2025-00015
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    June 21, 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

    IMPLANT LOOKED A LITTLE OFF FROM THE START. COULDN'T DIFFERENTIATE POROUS AND DENSE SIDE. BOTH LOOKED A LITTLE ROUGH AND THERE WASN'T A FLAT STRAIGHT SURFACE VISIBLE LIKE WE NORMALLY SEE ON THE DENSE SIDE. SURGEON PASSED TWO SUTURE TAPE TAILS THROUGH THE IMPLANT, BOTH TOWARDS THE MIDDLE OF THE IMPLANT. WHEN WE WENT TO HYDRATE, WE HYDRATED THE TOP HALF OF THE IMPLANT AND IT HYDRATED WITHIN 20 SECONDS. WHEN THE SURGEON BEGAN TO SLIDE IT TOWARDS THE KNEE, IT COMPLETELY FELL OFF OF THE SUTURES OUTSIDE OF THE KNEE. WE OPENED A NEW IMPLANT AND PASSED THE CINCH SUTURES THROUGH IT AND IT HYDRATED MUCH MORE NORMALLY AND IMPLANTED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018451 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