BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTOS MILD DEVICE KIT

    MDR report key: 16380088 · Received February 15, 2023

    Report

    Report Number
    3006450448-2023-00001
    Event Type
    Injury
    Date Received
    February 15, 2023
    Date of Event
    January 16, 2023
    Report Date
    February 15, 2023
    Manufacturer
    VERTOS MEDICAL, INC.
    Product Code
    HRX
    UDI-DI
    B235MDK00010
    PMA / PMN Number
    K093062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6)2023, AN 85-YEAR-OLD MALE PATIENT HAD A 2 LEVEL (L3/4 AND L4/5) BILATERAL MILD PROCEDURE PERFORMED USING STREAMLINED TECHNIQUE WITHOUT EPIDUROGRAM UNDER IV MAC SEDATION. A VERTOS REPRESENTATIVE WAS PRESENT AND OBSERVED THAT THE TROCAR WAS PLACED SLIGHTLY LOW ON THE INFERIOR LAMINA AT ONE TREATMENT ZONE AND NOTICED SOME "SCRAPING" OF THE LAMINA AS IT WAS REPOSITIONED. APPROXIMATELY 15 MINUTES AFTER THE PROCEDURE, THE PATIENT REPORTED PAIN ON TREATMENT SIDE AND THE PHYSICIAN ADMINISTERED AN INJECTION TO TREAT THE PAIN AND THE PATIENT WAS RELEASED AFTERWARDS. THE FOLLOWING DAY, THE PATIENT REPORTED TO PHYSICIAN WITH ADDITIONAL PAIN AND ADDITIONAL INJECTIONS WERE GIVEN TO HELP THE PATIENT. THE PATIENT WAS SENT HOME AND THEN CALLED LATER REPORTING WORSENING SYMPTOMS AND THE PHYSICIAN TOLD PATIENT TO GO BACK TO HOSPITAL FOR EVALUATION. THE HOSPITAL HCP REPORTED IDENTIFYING A BLEED IN THE LUMBAR TO THORACIC CANAL AND PERFORMED LAMINECTOMY WITH EVACUATION OF HEMATOMA ON 1/18/2023. ON 1/19/2023, THE VERTOS REPRESENTATIVE WAS INFORMED BY THE ORIGINAL TREATING PHYSICIAN ABOUT THE HEMATOMA AND LAMINECTOMY. IT SHOULD BE NOTED THAT PATIENT SELECTION COULD HAVE CONTRIBUTED TO THIS EVENT, AS THE PATIENT REPORTEDLY HAD SEVERAL HEALTH FACTORS THAT COULD CONTRIBUTE TO POST-PROCEDURE BLEEDING. ALSO, THERE WAS NO REPORTED DEVICE FAILURE OR MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140622 VERTOS MILD DEVICE KIT MILD DEVICE KIT HRX VERTOS MEDICAL, INC. MDK-0001 070122-00572 B235MDK00010

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Required Intervention