BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT

    MDR report key: 22965619 · Received September 4, 2025

    Report

    Report Number
    3020652-2025-00022
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    May 28, 2024
    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

    BASED ON THE INVESTIGATION CONDUCTED TO DATE, IT WAS CONCLUDED THAT THE ADDITION OF BMAC AND PRP TO THE KNEE JOINT AT THE END OF THE PROCEDURE DILUTED THE BEAR IMPLANT, AND IT MAY HAVE PREMATURELY WASHED OUT OF THE JOINT. THE BEAR IMPLANT IFU INDICATED THAT THE KNEE JOINT SHOULD BE THOROUGHLY DRY TO ENSURE THAT NO OTHER LIQUIDS DILUTE THE BEAR IMPLANT HYDRATED WITH THE WHOLE BLOOD.

    Description of Event or Problem · 0

    THE BEAR PATIENT'S MOM EMAILED MIACH INDICATING THAT THE BEAR SURGERY DID NOT TREAT/FIX HER DAUGHTER'S ACL. HER DAUGHTER HAD AN 9 MO MRI AND THE ACL LOOKED TORN. (B)(6) CALLED THE PATIENT'S MOM ON (B)(6) 2024 BASED ON THE EMAIL SHE HAD SENT MIACH WHEN THE MOM NOTIFIED THAT SHE THINKS THE ACL WAS NOT REGROWN WITH THE BEAR IMPLANT. SHE SAID THE DAUGHTER DID NOT HAVE AN INJURY, JUST A TWIST TO HER KNEE THEN SHE STARTED FEELING THAT IT WAS UNSTABLE. (B)(6) ALSO SPOKE WITH THE DR. ON (B)(6) 2024 TO UNDERSTAND IF THERE WAS ANYTHING OUT OF THE ORDINARY DURING THE SURGERY. DR. INDICATED THE PATIENT WAS SLOW MOVING DURING THE INITIAL PART OF REHAB AND THE ONLY THING DURING SURGERY THAT WAS OUT OF THE ORDINARY WAS THAT HE ADDED BMAC AND PRP TO THE KNEE AT THE END OF THE SURGERY BECAUSE THE PATIENT ALSO HAD A MENISCUS TEAR THAT HE TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1809767 BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT Resorbable implant for anterior cruciate ligament (ACL) repair QNI MIACH ORTHOPAEDICS 7009360 00860002987804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown