BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENISCAL REPAIR DEVICE CURVED

    MDR report key: 10777399 · Received November 3, 2020

    Report

    Report Number
    8043971-2020-05720
    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    IT WAS REPORTED THAT THE FIRST IMPLANT DEPLOYED BUT WHEN THE NEEDLE WAS RETRACTED. THE TIP HAD BROKEN OFF. THE TIP WAS REMOVED FROM THE PATIENT; IT REQUIRED AN ADDITIONAL INCISION AND HE CHANGED THE MENISCAL REPAIR TO A MINI OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241065 MENISCAL REPAIR DEVICE CURVED MENISCAL REPAIR DEVICE CURVED MBI T.A.G. MEDICAL PRODUCTS CORPORATION LTD AR-4570 20A21 01081867402178

    Patients

    Seq Age Sex Outcome Treatment
    1