BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTOS MILD DEVICE KIT

    MDR report key: 10093534 · Received May 27, 2020

    Report

    Report Number
    3006450448-2020-00001
    Event Type
    Injury
    Date Received
    May 27, 2020
    Date of Event
    April 16, 2020
    Report Date
    April 27, 2020
    Manufacturer
    VERTOS MEDICAL INC.
    Product Code
    HRX
    UDI-DI
    B235MDK00010
    PMA / PMN Number
    K093062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PATIENT COMPLAINED OF LOWER BACK AND BUTTOCK PAIN AFTER UNDERGOING A MILD PROCEDURE ON (B)(6) 2020. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND DIAGNOSED WITH AN EPIDURAL HEMATOMA AND DUROTOMY. A NEUROSURGERON PERFORMED A DECOMPRESSIVE LAMINECTOMY FROM L2 THRU L5 AND EVACUATED THE HEMATOMA AND REPAIRED THE DUROTOMY. THE PATIENT WAS THEN DISCHARGED FROM THE HOSPITAL. UPON FOLLOW-UP, IT WAS DETERMINED THE PATIENT NEEDED ADDITIONAL SURGERY TO REPAIR A SUSPECTED CSF LEAK. WITHOUT OPERATIVE NOTES AND LOCATION OF THE EPIDURAL NEEDLE IT IS UNCLEAR IF THE MILD DEVICE OR EPIDURAL NEEDLE CAUSED THE HEMATOMA AND DUROTOMY. NO FOLLOW-UP INFORMATION ON THE LAST SURGICAL PROCEDURE AND PATIENT OUTCOME WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556437 VERTOS MILD DEVICE KIT MILD DEVICE KIT HRX VERTOS MEDICAL INC. MDK-0001 B235MDK00010

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention