BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSIGN

    MDR report key: 17235379 · Received June 30, 2023

    Report

    Report Number
    9710376-2023-00001
    Event Type
    Injury
    Date Received
    June 30, 2023
    Date of Event
    June 20, 2023
    Report Date
    June 30, 2023
    Manufacturer
    TECHNOMED EUROPE
    Product Code
    GXZ
    UDI-DI
    08718375864845
    PMA / PMN Number
    K130136
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE METAL PORTION OF THE NEEDLE ELECTRODE BROKE OFF IN THE PATIENT AND HAD TO BE CUT OUT. A SCOLIOSIS CORRECTION WAS BEING PERFORMED. ALL NEEDLE ELECTRODES, GROUNDS, CORKSCREWS AND ADHESIVE ELECTRODE PLACED AS USUAL AND PROCEDURE COMMENCED. NOTHING UNUSUAL TO REPORT DURING THE PROCEDURE. AFTER THE PROCEDURE, IT WAS NOTICED ONE NEEDLE WAS MISSING, AN X-RAY WAS TAKEN AND THE NEEDLE FOUND IN THE PATIENT, AT THE KNEE. THE NEEDLE WAS CUT OUT TO BE REMOVED. THE PATIENT IS DOING FINE. THERE WAS NO CHANGE IN SURGICAL OUTCOME AND NO IMPACT ON PATIENT HEALTH. THE NEEDLE COULD EASILY BE FOUND AND THE CUT MADE WAS DESCRIBED AS VERY SMALL. A SMALL PLASTER AND FEW STITCHES WERE USED TO CLOSE THE WOUND.

    Description of Event or Problem · 0

    THE METAL PORTION OF THE NEEDLE ELECTRODE BROKE OFF IN THE PATIENT AND HAD TO BE CUT OUT. A SCOLIOSIS CORRECTION WAS BEING PERFORMED. ALL NEEDLE ELECTRODES, GROUNDS, CORKSCREWS AND ADHESIVE ELECTRODE PLACED AS USUAL AND PROCEDURE COMMENCED. NOTHING UNUSUAL TO REPORT DURING THE PROCEDURE. AFTER THE PROCEDURE, IT WAS NOTICED ONE NEEDLE WAS MISSING, AN X-RAY WAS TAKEN AND THE NEEDLE FOUND IN THE PATIENT, AT THE KNEE. THE NEEDLE WAS CUT OUT TO BE REMOVED. THE PATIENT IS DOING FINE. THERE WAS NO CHANGE IN SURGICAL OUTCOME AND NO IMPACT ON PATIENT HEALTH. THE NEEDLE COULD EASILY BE FOUND AND THE CUT MADE WAS DESCRIBED AS VERY SMALL. A SMALL PLASTER AND FEW STITCHES WERE USED TO CLOSE THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854917 NEUROSIGN DISPOSABLE TWISTED PAIR ELECTRODE GXZ TECHNOMED EUROPE 1699-00-TE 056631 OR 054787 08718375864845

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Female Other