BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT

    MDR report key: 23271880 · Received October 10, 2025

    Report

    Report Number
    3020652-2025-00027
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    September 5, 2025
    Report Date
    October 10, 2025
    Manufacturer
    MIACH ORTHOPAEDICS
    Product Code
    QNI
    PMA / PMN Number
    K243578
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CASE WAS COMPLETED SUCCESSFULLY WITH THE IMPLANT.

    Description of Event or Problem · 0

    DOCTOR NOTIFIED MIACH ON (B)(6) 2025 THAT THE BEAR IMPLANT HYDRATED TOO QUICKLY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2279769 BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT Resorbable implant for anterior cruciate ligament (ACL) repair QNI MIACH ORTHOPAEDICS 7011098

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown