BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTOS MILD DEVICE KIT

    MDR report key: 20103115 · Received August 29, 2024

    Report

    Report Number
    3006450448-2024-00012
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    May 18, 2024
    Report Date
    August 29, 2024
    Manufacturer
    VERTOS MEDICAL INC.
    Product Code
    HRX
    PMA / PMN Number
    K093062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A 70 Y/O MALE PATIENT HAD A BILATERAL L2-L3, L3-4 MILD PROCEDURE ON (B)(6) 2024. IT WAS REPORTED BY THE PHYSICIAN TO A COMPANY REPRESENTATIVE ON 7/30/2024 THAT THE PATIENT HAD GONE TO THE EMERGENCY ROOM WITH AN EPIDURAL BLEED AFTER RETAKING BLOOD THINNERS ON (B)(6). PATIENT RECEIVED A CT SCAN TO CONFIRM AN EPIDURAL HEMATOMA AND A LAMINECTOMY WAS PERFORMED. THE PATIENT HAD PREVIOUSLY BEEN ON BLOOD THINNERS (ELIQUIS) FOR A-FIB AND NO STOP DATE WAS REPORTED. IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN ACCORDANCE WITH PHYSICIAN TRAINING AND THAT THERE WAS NOTHING UNUSUAL ABOUT THE PATIENTS' ANATOMY. THERE WAS NOTHING REPORTED ON THE PATIENT'S CURRENT CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1793745 VERTOS MILD DEVICE KIT MILD DEVICE KIT HRX VERTOS MEDICAL INC. MDK-0001

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Hospitalization| R