BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTOS MILD DEVICE KIT

    MDR report key: 20072506 · Received August 26, 2024

    Report

    Report Number
    3006450448-2024-00011
    Event Type
    Injury
    Date Received
    August 26, 2024
    Date of Event
    July 21, 2024
    Report Date
    August 26, 2024
    Manufacturer
    VERTOS MEDICAL INC.
    Product Code
    HRX
    UDI-DI
    B235MDK00010
    PMA / PMN Number
    K093062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A PATIENT WHO WAS TREATED ON 6/25 WITH A BILATERAL L3-L4 MILD PROCEDURE, WAS SEEN IN OFFICE BY THE TREATING PHYSICIAN AS FOLLOW-UP ON 7/22 WITH SITE TENDERNESS, FLUCTUANT, AND DRAINAGE WAS DETERMINED TO HAVE DEVELOPED AN INFECTION. AN MRI WITH CONTRAST SHOWED 9MM SUBCUTANEOUS ENHANCING COLLECTION CONCERNING FOR ACCESS AT THE L4-5 LEVEL WITH EXTENSION OF INFLAMMATION INTO THE BILATERAL PARASPINAL MUSCLES (R>L). THERE WAS NO CONCERN FOR EXTENSION INTO THE SPINAL CANAL. THE PATIENT'S POST-PROCEDURAL PAIN WAS MANAGEABLE, AND THE PATIENT DENIED EXPERIENCING ANY SYMPTOMS OF FEVERS, CHILLS, WEAKNESS, NUMBNESS, OR INCONTINENCE AFTER THE MILD PROCEDURE. INFORMATION SUCH AS THE PATIENT'S ADHERENCE TO ANY RECOVERY REGIMENT, INCLUDING THE PATIENT'S LAST STEROID USE DURING RECOVERY, DIABETIC STATUS, OR ANY PREVIOUS HEALTH ISSUES WITH POST-PROCEDURAL HEALING OR ONGOING SYSTEMIC INFECTIONS COULD NOT BE OBTAINED. THE PATIENT WAS TREATED IN THE HOSPITAL WITH IV ANTIBIOTICS FOR THE INFECTION AND DISCHARGED ON 7/25A PATIENT WHO WAS TREATED ON 6/25 WITH A BILATERAL L3-L4 MILD PROCEDURE, WAS SEEN IN OFFICE BY THE TREATING PHYSICIAN AS FOLLOW-UP ON 7/22 WITH SITE TENDERNESS, FLUCTUANT, AND DRAINAGE WAS DETERMINED TO HAVE DEVELOPED AN INFECTION. AN MRI WITH CONTRAST SHOWED 9MM SUBCUTANEOUS ENHANCING COLLECTION CONCERNING FOR ACCESS AT THE L4-5 LEVEL WITH EXTENSION OF INFLAMMATION INTO THE BILATERAL PARASPINAL MUSCLES (R>L). THERE WAS NO CONCERN FOR EXTENSION INTO THE SPINAL CANAL. THE PATIENT'S POST-PROCEDURAL PAIN WAS MANAGEABLE, AND THE PATIENT DENIED EXPERIENCING ANY SYMPTOMS OF FEVERS, CHILLS, WEAKNESS, NUMBNESS, OR INCONTINENCE AFTER THE MILD PROCEDURE. INFORMATION SUCH AS THE PATIENT'S ADHERENCE TO ANY RECOVERY REGIMENT, INCLUDING THE PATIENT'S LAST STEROID USE DURING RECOVERY, DIABETIC STATUS, OR ANY PREVIOUS HEALTH ISSUES WITH POST-PROCEDURAL HEALING OR ONGOING SYSTEMIC INFECTIONS COULD NOT BE OBTAINED. THE PATIENT WAS TREATED IN THE HOSPITAL WITH IV ANTIBIOTICS FOR THE INFECTION AND DISCHARGED ON 7/25.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968107 VERTOS MILD DEVICE KIT MILD DEVICE KIT HRX VERTOS MEDICAL INC. MDK-0001 B235MDK00010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization