BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTOS MILD DEVICE KIT

    MDR report key: 19715571 · Received July 10, 2024

    Report

    Report Number
    3006450448-2024-00009
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    March 18, 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
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2022, A FEMALE PATIENT UNDERWENT A BILATERAL, 2 LEVEL MILD PROCEDURE. AN EPIDUROGRAM WAS PERFORMED AT THE LEVEL ABOVE USING A 20 GAUGE TOUHY NEEDLE. THE PATIENT WAS REPORTED TO BE OF AVERAGE SIZE AND WEIGHT AND STOPPED ALL MEDICATIONS INCLUDING ANTICOAGULANTS 7-10 DAY BEFORE THE PROCEDURE. THE PATIENT HAD ISSUES OF HYPOTENSION DURING THE PROCEDURE AND WAS TREATED WITH 20MG EPHEDRINE AND A 500ML BOLUS OF FLUID. THE PHYSICIAN HAD SOME IMAGING ISSUES DUE TO THE ANATOMY AND SEEING MARKERS THAT RESULTED IN USING MORE THAT 15 MINUTES OF FLUOROSCOPY TIME. THE PATIENT COMPLAINED OF NEUROGENIC CLAUDICATION AND BACK PAIN THE NEXT DAY ( ON (B)(6)2022). AN MRI WAS PERFORMED AND SHOWED "HETEROGENEOUS BILOBED FLUID COLLECTION IN THE DORSAL EPIDURAL SPACE ALONG THE DORSAL THECAL SAC. FLUID COLLECTION REPRESENTED POST OP HEMATOMA GIVEN CHARACTERISTICS". THE PATIENTS PAIN CONTINUED FOR 1 WEEK WHEN A SURGICAL INTERVENTION FOR THE SUBDURAL HEMATOMA WAS PERFORMED ON (B)(6) 2022. THE SURGEON DID NOT FIND A DORSAL EPIDURAL TEAR. THERE WAS AN OSTEOPHYTE NOTED ON THE FACET GOING MEDIALLY WITH A "SMALL VESSEL ABOVE IT THAT MAY HAVE BEEN INJURED DURING THE PROCEDURE" - THIS WAS THEIR BEST GUESS. THE PATIENT IS REPORTEDLY DOING WELL AFTER THE SUBDURAL HEMATOMA WAS ADDRESSED. OFF ALL PAIN MEDICATION AND MUCH BETTER FUNCTIONALLY. THERE IS NOTHING IN THE INFORMATION THAT WAS OBTAINED THAT SUGGESTS ANY DEVICE MALFUNCTION CONTRIBUTED TO THIS EVENT. PATIENT SELECTION (DIFFICULT ANATOMY) MAY HAVE CONTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2165102 VERTOS MILD DEVICE KIT MILD DEVICE KIT HRX VERTOS MEDICAL INC. MDK-0001 B235MDK00010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention