BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTOS MILD DEVICE KIT

    MDR report key: 18373867 · Received December 21, 2023

    Report

    Report Number
    3006450448-2023-00010
    Event Type
    Injury
    Date Received
    December 21, 2023
    Date of Event
    November 21, 2023
    Report Date
    December 21, 2023
    Manufacturer
    VERTOS MEDICAL INC.
    Product Code
    HRX
    UDI-DI
    B235MDK00010
    PMA / PMN Number
    K093062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A VERTOS MEDICAL SALES REPRESENTATIVE RECEIVED INFORMATION REGARDING A PATIENT EXPERIENCING SEVERE PAIN POST-OPERATIVELY (REPORTED BACK, LEG, AND BUTT PAIN) FOLLOWING A MILD PROCEDURE COMPLETED THE SAME DAY (B)(6) 2023). THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6), WHERE A LAMINECTOMY WAS PERFORMED ON (B)(6) TO ADDRESS POST-PROCEDURAL COMPLICATIONS. THE PATIENT WAS LAST DISCHARGED ON (B)(6) 2023 AWAITING APPROVAL FOR PHYSICAL THERAPY; NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2153188 VERTOS MILD DEVICE KIT MILD DEVICE KIT HRX VERTOS MEDICAL INC. MDK-0001 B235MDK00010

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention