BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTOS MILD DEVICE KIT

    MDR report key: 19715435 · Received July 10, 2024

    Report

    Report Number
    3006450448-2024-00008
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    March 17, 2022
    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
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2022 A PHYSICIAN PERFORMED A BILATERAL L3-L4, L4-L5 MILD PROCEDURE ON A 75Y/O FEMALE PATIENT WITH A HISTORY OF URINARY INCONTINENCE (2008) AND OSTEOARTHRITIS. FROM IMAGING, THE PATIENT WAS NOTED TO HAVE SEVERE STENOSIS, GRADE 1 SPONDYLOLISTHESIS, AND FACET CYST. THE CASE REPORTEDLY WENT WELL. ON (B)(6) 2022 THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO URINARY INCONTINENCE AND NUMBNESS IN THE GENITAL AREA. THE PATIENT WAS PLACED IN THE CARE OF A NEUROSURGEON. AN MRI WAS PERFORMED AND THERE WAS NO EVIDENCE OF AN EPIDURAL HEMATOMA, HOWEVER THE STENOSIS WAS WORSE THAN PRIOR TO THE PROCEDURE. THE PATIENT WAS DIAGNOSED WITH CAUDA EQUINA SYNDROME, A BUCKLED LIGAMENT AT L4-L5, AND UNDERWENT EMERGENT SURGERY. THE PATIENT IS CURRENTLY STABLE, FULL STRENGTH IN LEGS, WORSENED URINARY RETENTION AND HAS IMPROVEMENT IN NUMBNESS. UPDATED REPORT FROM TREATING PHYSICIAN DATED (B)(6) 2022 STATED THAT PATIENT REMAINED IN THE HOSPITAL AND REMAIN FLAT FOR 7 DAYS BEFORE DISCHARGE FOLLOWING THE EMERGENT SURGERY BECAUSE OF A CSF LEAK. AT THE TIME OF THE COMPLAINT INVESTIGATION, THE PATIENT WAS IN REHAB DUE TO ONGOING URINARY INCONTINENCE. THE PHYSICIANS' PATIENT SELECTION AND PRE-PROCEDURE EVALUATION (GRADE 1 SPONDYLOLISTHESIS, FACET CYST, SEVERE STENOSIS - WITH NO DOCUMENTED FLEXION/EXTENSION IMAGES TO CHECK FOR STABILITY) MAY HAVE CONTRIBUTED TO THE OCCURRENCE OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351704 VERTOS MILD DEVICE KIT MILD DEVICE KIT HRX VERTOS MEDICAL INC. MDK-0001 B235MDK00010

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention