BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENISCAL REPAIR DEVICE CURVED

    MDR report key: 10777398 · Received November 3, 2020

    Report

    Report Number
    8043971-2020-05620
    Event Type
    Malfunction
    Date Received
    November 3, 2020
    Date of Event
    September 17, 2020
    Report Date
    October 17, 2020
    Manufacturer
    T.A.G. MEDICAL PRODUCTS CORPORATION LTD
    Product Code
    MBI
    UDI-DI
    01081867402178
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON COMPLAINT DESCRIPTION, DUE TO FACT THAT PRODUCT WAS NOT RETURNED , INVESTIGATION RAISED THAT IT IS POSSIBLE THAT THE DEVICE HIT HARD TISSUE OR BON AND THEREFORE MISUSED. IT WAS CONCLUDED THAT, SUCH MISUSE LED TO PRODUCT BREAKAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A KNEE ARTHROSCOPY WITH A MENISCAL REPAIR THE IMPLANT BENT DURING INSERTION. IT WAS REMOVED AND THE CASE WAS COMPLETED. TWO OTHER IMPLANTS WERE USED. ONE WAS THE SAME LOT NUMBER AND THE OTHER WAS DIFFERENT. THEY WERE BOTH IMPLANTED WITH NO ISSUES. THE PATIENT RETURNED TO THE OFFICE FOR A FOLLOW UP AND WAS COMPLAINING OF PAIN. THE DOCTOR PERFORMED AN X-RAY AND DETERMINED THERE WAS A PIECE OF THE INSERTER STILL IN THE KNEE. THE FRAGMENT WAS REMOVED IN THE OFFICE WITH LOCAL ANESTHESIA AND DID NOT HAVE TO RETURN TO THE OPERATING ROOM CURRENTLY THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241064 MENISCAL REPAIR DEVICE CURVED MENISCAL REPAIR DEVICE CURVED MBI T.A.G. MEDICAL PRODUCTS CORPORATION LTD AR-4570 19R04 01081867402178

    Patients

    Seq Age Sex Outcome Treatment
    1