BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT

    MDR report key: 22964132 · Received September 4, 2025

    Report

    Report Number
    3020652-2025-00007
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    September 1, 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 AS NORMAL.

    Description of Event or Problem · 0

    THE DEVICE LOOKED NORMAL WITH NO DEFECTS WHEN REMOVED FROM THE PACKAGE. A SMALL SECTION OF THE BASE OF THE IMPLANT DID NOT ABSORB BLOOD COMPLETELY (IT REMAINED FIRM AND DID NOT SOFTEN) AND BROKE OFF FROM THE REST OF THE IMPLANT WHILE THE KNEE WAS BEING CLOSED. SIZE OF THE SECTION WAS APPROXIMATELY 0.5" X 0.5". A TOTAL OF 12 ML OF BLOOD WERE APPLIED TO THE IMPLANT, WITH APPROXIMATELY 3-4 ML RUNOFF. DR WAS NOT CONCERNED WITH THE PATIENT OR EVENT. PROCEDURE WAS COMPLETED AS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1675702 BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT Resorbable implant for anterior cruciate ligament (ACL) repair QNI MIACH ORTHOPAEDICS 7008432 00860002987804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown