BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT

    MDR report key: 23607598 · Received November 20, 2025

    Report

    Report Number
    3020652-2025-00028
    Event Type
    Injury
    Date Received
    November 20, 2025
    Date of Event
    December 9, 2022
    Report Date
    November 18, 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

    PATIENT PROVIDED SURGEON REPORTS THAT DO NOT SUBSTANTIATE THE PATIENT'S CLAIMS THAT THE BEAR IMPLANT "WAS INFORMED THAT THE BEAR IMPLANT HAD NOT BEEN ENTIRELY SUCCESSFUL AND HAD CAUSED SECONDARY DAMAGE TO MY CARTILAGE, LEADING TO THE DEVELOPMENT OF ARTHRITIS". THE POST SURGERY REPORT DATED (B)(6) 2023 INDICATE THE ACL IS "INTACT" AND "IN SATISFACTORY ALIGNMENT". THE SECOND SURGERY REPORT DATED (B)(6) 2023 INDICATED THAT THE PATIENT HAD A RIGHT KNEE MEDIAL MENISCUS TEAN AND THE ACL IS INTACT WHILE INDICATING THAT THE PATIENT MAY HAVE SOME RECURRENT TEARING OF HIS MEDIAL MENISCUS. THE OPERATIVE FINDINGS IDENTIFIED THE ACL AS "OVERALL INTACT". POSTOPERATIVE CHANGES OF PRIOR ACL REPAIR/AUGMENTATION. ACL FIBERS ARE SOMEWHAT INDISTINCT AND IRREGULAR LIKELY REPRESENTING A COMPONENT OF HEALING/SCARRING. NO FLUID FILLED DEFECT TO SUGGEST RECURRENT TEAR. THE POST SURGERY REPORTS INDICATE THAT THE BEAR IMPLANT PERFORMED AS INTENDED AND THERE WERE NO PRODUCT DEFECTS.

    Description of Event or Problem · 0

    PATIENT EMAILED THE CUSTOMER SERVICE TEAM ON (B)(6) 2025 TO "ASKING FOR A RESOLUTION/GUIDANCE FOR MY BEAR IMPLANT CASE". IN (B)(6) 2022 THE PATIENT TORE THEIR RIGHT KNEE ACL AND MENISCUS. THE PATIENT TRAVELED FROM (B)(6) TEXAS, WHERE THE ORTHOPAEDIC SURGEON PERFORMED THE ACL BEAR IMPLANT PROCEDURE AND ALSO REPAIRED THEIR MENISCUS ON (B)(6) 2022. 11 MONTHS POST-SURGERY, THE PATIENT REPORTED THAT MY KNEE HAD NOT IMPROVED. AT THAT TIME, HE WAS RECOMMENDED TO GET AN MRI. IN (B)(6) 2023, THE PATIENT UNDERWENT A SECOND SURGERY AND RESUMED PHYSICAL THERAPY IMMEDIATELY AFTERWARD. THE PATIENT CLAIMS THAT THEY WERE INFORMED THAT THE BEAR IMPLANT HAD NOT BEEN ENTIRELY SUCCESSFUL AND HAD CAUSED SECONDARY DAMAGE TO MY CARTILAGE, LEADING TO THE DEVELOPMENT OF ARTHRITIS. THE PATIENT VISITED A SURGEON IN MAYO CLINIC, SPORT CENTER. THEY PERFORMED AN EXTENSIVE EVALUATION OF THEIR KNEE.. AN MRI AND X-RAYS REVEALED THAT MY BEAR ACL IMPLANT HAD NEARLY FAILED, WITH ONLY THE IMPLANT'S STRINGS STILL HOLDING IT IN PLACE. THIS HAS ALSO CAUSED THE PCL TO BUCKLE. FURTHERMORE, THEY FOUND SIGNIFICANT DAMAGE TO MY KNEE CARTILAGE, NOTING THAT THE PATIENT HAD LOST NEARLY 20% OF MY CARTILAGE COMPARED TO THEIR HEALTHY LEFT KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293699 BRIDGE-ENHANCED ACL RESTORATION (BEAR) IMPLANT Resorbable implant for anterior cruciate ligament (ACL) repair QNI MIACH ORTHOPAEDICS 7008409 00860002987804

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male