BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT

    MDR report key: 21868160 · Received April 18, 2025

    Report

    Report Number
    3020652-2025-00001
    Event Type
    Injury
    Date Received
    April 18, 2025
    Date of Event
    March 10, 2025
    Report Date
    April 18, 2025
    Manufacturer
    MIACH ORTHOPAEDICS
    Product Code
    QNI
    UDI-DI
    00860002987804
    PMA / PMN Number
    K243578
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    PATIENT EMAILED MIACH ORTHOPAEDICS TO INFORM THE TEAM OF AN INFECTION ON (B)(6) 2025. THE FEMALE PATIENT INFORMED MIACH ORTHOPAEDICS THAT ON (B)(6) 2025, SHE HAD HER KNEE DRAINED AND AN EMERGENCY WASHOUT PERFORMED WHICH REMOVED ANY OR THE REMAINING BEAR IMPLANT NOT YET DISSOLVED. THE INFECTION WAS CONFIRMED ON (B)(6) 2025 AND PATIENT WAS PLACED ON AN ORAL ANTIBIOTIC OF CIPROFLOXACIN. AN INFECTIOUS DISEASE DOCTOR WAS SEEN ON (B)(6) 2025 AND WAS GIVEN CEFEPIME VIA IV FOR FOUR WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1682016 BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT BEAR IMPLANT, PRODUCT CODE QNI QNI MIACH ORTHOPAEDICS 7010533 00860002987804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other