BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT

    MDR report key: 23782779 · Received December 11, 2025

    Report

    Report Number
    3020652-2025-00030
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    April 17, 2023
    Report Date
    November 12, 2025
    Manufacturer
    MIACH ORTHOPAEDICS
    Product Code
    QNI
    UDI-DI
    00860002987804
    PMA / PMN Number
    K243578
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    STILL UNDER INVESTIGATION. WILL SUBMIT A FOLLOW UP MDR.

    Description of Event or Problem · 0

    PATIENT STATED: "IT'S IMPORTANT TO INFORM (B)(6) AND MIACH THAT I HAD SIGNIFICANT PAIN FOLLOWING THE SURGERY. THE SURGEON DECIDED TO INCLUDE A CHONDROPLASTY AND MENISCUS SURGERY WHILE REPAIRING MY ACL. AFTER SURGERY, I HAVE HAD CONSTANT PAIN AND IT'S STILL BOTHERING ME TODAY. I WAS UNABLE TO WALK UP AND DOWN STAIRS WITHOUT SIGNIFICANT PAIN FOR OVER A YEAR AND A HALF." AND "I ALSO HAVE A BUMP THAT APPEARED IMMEDIATELY AFTER SURGERY ON MY RIGHT KNEE THAT LOOKS LIKE OSGOOD SCHLATTER DISEASE. THE BUMP WAS NOT PRESENT BEFORE SURGERY. I ASKED THE SURGEON ABOUT THE BUMP AND HE SAID IT WAS FROM SWELLING. IT'S STILL PRESENT ON MY KNEE AND PROTRUDES EVEN MORE SINCE THE SWELLING HAS SUBSIDED. MY RIGHT KNEE CONTINUES POPPING, CRACKING AND CATCHING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2313347 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 63 YR Female