BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTOS MILD DEVICE KIT

    MDR report key: 19715635 · Received July 10, 2024

    Report

    Report Number
    3006450448-2024-00006
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    December 10, 2020
    Report Date
    July 10, 2024
    Manufacturer
    VERTOS MEDICAL INC.
    Product Code
    HRX
    UDI-DI
    B235MDK00010
    PMA / PMN Number
    K093062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2020, A 74 Y/O FEMALE PATIENT HAD A BILATERAL L4-L5 MILD PROCEDURE. THE PATIENT HAD BEEN ON ANTICOAGULANTS THAT WERE REPORTEDLY STOPPED IN AN APPROPRIATE TIMEINE BEFORE THE PROCEDURE. AN EPIDUROGRAM WAS REPORTED AS PERFORMED AT L3-L4 DUE TO DIFFICULTY ACCESSING THE L4-L5 FOR THE EPIDUROGRAM. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE DEVICE PERFORMED AS INTENDED. APPROXIMATELY 2 HOURS FOLLOWING THE PROCEDURE, THE PATIENT COMPLAINED OF SEVERE BACK PAIN AND LEG WEAKNESS AND WENT FROM HOME TO THE ER. AN MRI WAS PERFORMED, AND AN EPIDURAL HEMATOMA WAS IDENTIFIED. THE PATENT UNDERWENT SPINE SURGERY AND HAD THE HEMATOMA EVACUATED ONE DAY AFTER THE MILD PROCEDURE. IT WAS REPORTED THAT THE HEMATOMA WAS AT T-11 AND THE MILD PROCEDURE WAS PERFORMED MUCH LOWER AT L4-L5 WITH EPIDUROGRAM AT L3-L4 IN THE LUMBAR SPINE THEREFORE IT CANNOT BE DETERMINED WHAT CAUSED THE HEMATOMA. THE PATIENT RECOVERED AFTER THE UNEVENTFUL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2148089 VERTOS MILD DEVICE KIT MILD DEVICE KIT HRX VERTOS MEDICAL INC. MDK-0001 B235MDK00010

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention