BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X CLOSE PLUS

    MDR report key: 5952372 · Received September 9, 2016

    Report

    Report Number
    MW5064766
    Event Type
    Malfunction
    Date Received
    September 9, 2016
    Date of Event
    August 30, 2016
    Report Date
    September 9, 2016
    Manufacturer
    KR MEDICAL TECHNOLOGIES
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING AN L4-5 AND L5-S1 MICRODISCECTOMY PROCEDURE IN OUR MAIN OPERATING ROOM, THE TIP OF THE SUTURE DELIVERY (X CLOSE PLUS - KR MEDICAL TECHNOLOGIES) BROKE OFF AND WAS FISHED OUT PRIOR TO CLOSURE WITH THE SUTURE STILL ATTACHED. X CLOSE PLUS SYSTEM USED X2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590923 X CLOSE PLUS SUTURE NONABSORBABLE GAT KR MEDICAL TECHNOLOGIES 218107116

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR