BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT

    MDR report key: 22965573 · Received September 4, 2025

    Report

    Report Number
    3020652-2025-00021
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    April 16, 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

    THE CASE WAS COMPLETED WITH A SECOND IMPLANT.

    Description of Event or Problem · 0

    EARLIER THIS WEEK, WE HAD AN IMPLANT DISINTEGRATE. I ASKED THE DOCTOR TO EXPLAIN IN HIS WORDS AND HE SAID, IT DISINTEGRATED - THERE WAS HARDLY ANYTHING LEFT. NO CLOT. NOTHING. I SUGGESTED WE OPEN ANOTHER IMPLANT AND THIS ONE DID NOT WANT TO HYDRATE. SAME LOT, SAME TECHNIQUE. WHEN HE WENT TO IMPLANT, A CHUNK OF THE IMPLANT BROKE OFF. THE CASE WAS COMPLETED WITH A SECOND IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1675789 BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT Resorbable implant for anterior cruciate ligament (ACL) repair QNI MIACH ORTHOPAEDICS 7009361 00860002987804

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown