BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTOS MILD DEVICE KIT

    MDR report key: 20293200 · Received September 24, 2024

    Report

    Report Number
    3006450448-2024-00015
    Event Type
    Injury
    Date Received
    September 24, 2024
    Date of Event
    September 4, 2019
    Report Date
    September 24, 2024
    Manufacturer
    VERTOS MEDICAL INC.
    Product Code
    HRX
    UDI-DI
    B235MDK00010
    PMA / PMN Number
    K093062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2019, A 73 YEAR-OLD FEMALE PATIENT HAD A MILD PROCEDURE PERFORMED ON L2-L3 AND L3-L4, FOLLOWED BY AN EPIDURAL STEROID INJECTION AT THE SAME LEVELS. IMMEDIATELY FOLLOWING THE PROCEDURE, SHE NOTED SEVERE LOWER BACK AND RIGHT LEG PAIN. AN MRI WAS DONE AND WAS INCONCLUSIVE. A CET WITH MYELOGRAM SHOWED AN L1-L2 EPIDURAL HEMATOMA. THE PATIENT HAD TWO DECOMPRESSION LAMINECTOMIES PERFORMED BY A NEUROSURGEON FOLLOWING THE MILD PROCEDURE AND WAS PLACED IN AN INPATIENT REHAB TO RECOVER. THE PATIENT HISTORY PRIOR TO THE MILD PROCEDURE INCLUDED A FUSION AT L4-L5 WITH POSTERIOR INSTRUMENTATION AND SPINAL CORD STIMULATOR WITH ANCHORS OVERLYING THE RIGHT L2-L3 AND L3-L4 INTERSPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2016081 VERTOS MILD DEVICE KIT MILD DEVICE KIT HRX VERTOS MEDICAL INC. MDK-0001 B235MDK00010

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention