BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTOS MILD DEVICE KIT

    MDR report key: 19047620 · Received April 4, 2024

    Report

    Report Number
    3006450448-2024-00003
    Event Type
    Injury
    Date Received
    April 4, 2024
    Date of Event
    February 29, 2024
    Report Date
    April 4, 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) 2024, A MALE PATIENT HAD A L4-L5 MILD PROCEDURE PERFORMED. AN EPIDURAL WAS PERFORMED WITH THE MILD PROCEDURE AT THE L4-L5 LEVEL. NOTHING ABNORMAL WAS REPORTED REGARDING THE PROCEDURE OR THE PATIENT'S ANATOMY. ONE WEEK POST-OPERATIVE, THE PATIENT WAS EXPERIENCING INCREASED BACK AND LEG PAIN. AN MRI WAS PERFORMED, AND THE PATIENT WAS DIAGNOSED WITH A HEMATOMA NEAR THE TREATMENT AREA OF THE MILD PROCEDURE AT L5-S1. AS OF ON (B)(6) 2024, IT WAS CONFIRMED BY THE PHYSICIAN THAT THE PATIENT HAS NOT RECEIVED ANY INTERVENTIONAL TREATMENT BEYOND BED REST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90303 VERTOS MILD DEVICE KIT MILD DEVICE KIT HRX VERTOS MEDICAL INC. MDK-0001 B235MDK00010

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention