BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT

    MDR report key: 22846474 · Received August 19, 2025

    Report

    Report Number
    3020652-2025-00002
    Event Type
    Injury
    Date Received
    August 19, 2025
    Date of Event
    August 23, 2023
    Report Date
    August 19, 2025
    Manufacturer
    MIACH ORTHOPAEDICS
    Product Code
    QNI
    UDI-DI
    00860002987804
    PMA / PMN Number
    K243578
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DOCTOR REPORTED HE HAD A PATIENT THAT REQUIRED A WASHOUT DUE TO AN INFECTION (WASHED WITH VANC AND ZOSYN FOR BROAD SPECTRUM COVERAGE). THE PATIENT HAD SURGERY ON (B)(6) 2023 WITH NO ISSUES REPORTED. THE PATIENT FELL DOWN CHASING HER KID AND TWISTED HER KNEE AT 4.5 WEEKS POST OP. THE PATIENT WENT TO ER (6.5 WEEKS POST OP) WITH AN INFECTION. THE DOCTOR SCOPED THE KNEE WITH A LOT OF PUSS IN THE SUPRA-PATELLAR & IN THE JOINT. PHOTOS (ATTACHED) SHOW THAT THE ETHIBOND SUTURES WERE SNAPPED & THE ACL LOOKED MORE LIKE A "RE TEAR" THAN A "FAILURE TO HEAL". DR. SHAH BELIEVES THE INFECTION AND DAMAGED ACL ARE ATTRIBUTED TO THE TWIST & FALL + NONCOMPLIANCE, NOT THE BEAR IMPLANT ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1468423 BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT BEAR IMPLANT, PRODUCT CODE QNI, PRODUCT CODE: QNI QNI MIACH ORTHOPAEDICS 7009194 00860002987804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other