BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENISCAL REPAIR DEVICE CURVED

    MDR report key: 10777405 · Received November 3, 2020

    Report

    Report Number
    8043971-2020-04220
    Event Type
    Malfunction
    Date Received
    November 3, 2020
    Date of Event
    July 26, 2020
    Report Date
    July 26, 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

    THE FAILURE DESCRIBED BY CUSTOMER DOES NOT MATCH TO DEFINITIONS DESCRIBED IN IFU170AR REV 'E', SEEMS THAT END-USER USED EXCESSIVE TENSION OR OVERLOAD THE DEVICE. IT IS A CASE OF MISUSE BY PHYSICIAN. EFFECTIVE INVESTIGATION CAN'T BE PERFORMED BECAUSE DEVICE WAS NOT SHIPPED TO TAG

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SECOND IMPLANT ON THE AR-4570 WOULD NOT DEPLOY. THEY CUT THE SUTURE BUT DID NOT REMOVE THE FIRST IMPLANT WHICH IS BEHIND THE CAPSULE. WITH THE SECOND ATTEMPT, BOTH IMPLANTS SEATED, BUT PULLED OUT WHEN THE SURGEON WAS TENSIONING. THE CASE WAS COMPLETED WITH AN ARTHREX ZONE NAVIGATOR, WHICH REQUIRED AN ADDITIONAL INCISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241066 MENISCAL REPAIR DEVICE CURVED MENISCAL REPAIR DEVICE CURVED MBI T.A.G. MEDICAL PRODUCTS CORPORATION LTD AR-4570 20B04 01081867402178

    Patients

    Seq Age Sex Outcome Treatment
    1