BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT

    MDR report key: 22964778 · Received September 4, 2025

    Report

    Report Number
    3020652-2025-00014
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    February 24, 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 WITHOUT THE BEAR IMPLANT.

    Description of Event or Problem · 0

    (B)(4) DISTRIBUTOR REPORTED THE EVENT. THE BEAR IMPLANT BECAME OVERHYDRATED WITH THE PATIENT'S BLOOD AND TURNED TO MUSH. MOST, IF NOT ALL, OF THE IMPLANT WAS UNABLE TO BE INSERTED INTO THE PATIENT'S KNEE. THIS WAS A PROXIMAL TEAR. THE SURGEON WAS COMFORTABLE WITH A PRIMARY REPAIR WITHOUT BEAR AND CHOSE NOT TO OPEN AND HYDRATE ANOTHER BEAR IMPLANT. VERY MINIMAL TIME DELAY (2-3 MINUTES) AND NO ADVERSE PATIENT CONSEQUENCES EXPECTED. HYDRATION TOOK APPROXIMATELY 3 - 4 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2412487 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