BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTOS MILD DEVICE KIT

    MDR report key: 20257470 · Received September 19, 2024

    Report

    Report Number
    3006450448-2024-00013
    Event Type
    Injury
    Date Received
    September 19, 2024
    Date of Event
    August 16, 2024
    Report Date
    September 19, 2024
    Manufacturer
    VERTOS MEDICAL INC.
    Product Code
    HRX
    UDI-DI
    B235MDK00010
    PMA / PMN Number
    K093062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2024, A 71 YO MALE PATIENT HAD A BILATERIAL L-3-L4, L4-L5 MILD PROCEDURE. ON 8/23/2024, A VERTOS REPRESENTATIVE WAS CONTACTED BY THE TREATING PHYSICIAN WHO REPORTED THAT THE PATIENT HAD PAIN WHEN BENT OVER AND NUMBNESS IN THE LEG 4-6 HOURS AFTER THE PROCEDURE AND WENT TO THE HOSPITAL ON (B)(6) 2024. AN MRI SCAN SHOWED A HEMATOMA ON THE LEFT SIDE OF L3-L4. THE PATIENT WAS REFERRED TO A SURGEON AND UNDERWENT A SUCCESSFUL LAMINECTOMY ON (B)(6) 2024. PATIENT'S SPINE WAS FUSED FROM T10-S1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1431112 VERTOS MILD DEVICE KIT MILD DEVICE KIT HRX VERTOS MEDICAL INC. MDK-0001 B235MDK00010

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention