BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G-LOK WITH NO LOOP

    MDR report key: 10754616 · Received October 29, 2020

    Report

    Report Number
    8043971-2020-04520
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Date of Event
    July 27, 2020
    Report Date
    July 27, 2020
    Manufacturer
    T.A.G. MEDICAL PRODUCTS CORPORATION LTD
    Product Code
    MBI
    UDI-DI
    01081019001002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ITEM CONTAINS NO LOOP. ISSUE OCCURED DUE TO WRONG LOOP INSERTION THE LOOP SHOULD BE INSERTED IN ACCORDANCE WITH IFU234GRST REV. H (FIGURE 4.3), ENGINEERING DEPARTMENT ASSUME THAT DURING LOOP INSERTION PROCESS, TOO MUCH FORCE WAS APPLIED ON THE COVER AND IT PULLED OUT THE G-LOK BODY. THERE IS NO RISK TO PATIENT WITH THIS IMPLANT SINCE IT IS BIOCOMPATIBLE.

    Description of Event or Problem · 1

    THE SURGEON WAS USING THE NO-LOOP GLOK TO FIXATE A DISTAL BICEPS REPAIR. AFTER PASSING, THE SURGEON TESTED THE TENSION OF THE TENDON AND WANTED TO MAKE SURE THE BUTTON WAS AGAINST THE CORTEX, AND THE CENTER OF THE BUTTON SEEMED TO BREAK OFF, WITH SUTURE PULLING BACK THROUGH THE TUNNEL. THE PIECE AT THE CENTER OF THE BUTTON REMAINED IN THE PATIENT AND COULD NOT BE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224592 G-LOK WITH NO LOOP G-LOK WITH NO LOOP MBI T.A.G. MEDICAL PRODUCTS CORPORATION LTD 234100000 18E02 01081019001002

    Patients

    Seq Age Sex Outcome Treatment
    1