BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTOS MILD DEVICE KIT

    MDR report key: 19715558 · Received July 10, 2024

    Report

    Report Number
    3006450448-2024-00005
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    August 5, 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
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2020 THE PATIENT UNDERWENT A L4-L5 MILD PROCEDURE. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE DEVICE PERFORMED AS INTENDED. SIX DAYS FOLLOWING THE PROCEDURE, THE PATIENT PRESENTED TO THE HOSPITAL WITH SEVERE BACK PAIN ON (B)(6) 2020 AND WAS ADMITTED TO THE HOSPITAL. AN MRI SCAN SHOWED A EPIDURAL HEMATOMA AND AS A RESULT A MULTILEVEL LAMINECTOMY WAS PERFORMED. THE PATIENT WAS REPORTED TO BE STABLE WITH NO NEUROLOGIC COMPROMISE AT THE TIME OF THE COMPLAINT INVESTIGATION. IT SHOULD BE NOTED THAT THE PATIENT HAD LEUKEMIA AND HAD BEEN TAKING ELOQUIS THAT WAS STOPPED A WEEK BEFORE THE MILD PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2144703 VERTOS MILD DEVICE KIT MILD DEVICE KIT HRX VERTOS MEDICAL INC. MDK-0001 B235MDK00010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention