BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TX SYSTEM - TX2 MICROTIP

    MDR report key: 20176396 · Received September 9, 2024

    Report

    Report Number
    1000135560-2024-00033
    Event Type
    Injury
    Date Received
    September 9, 2024
    Date of Event
    September 8, 2023
    Report Date
    September 9, 2024
    Manufacturer
    TENEX HEALTH, INC.
    Product Code
    LFL
    UDI-DI
    00857156006154
    PMA / PMN Number
    K153299
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A PATIENT RETURNED TO SEE THEIR PHYSICIAN APPROXIMATELY ONE YEAR AFTER A PROCEDURE WITH THE TENEX SYSTEM. THE PATIENT HAD FOOT PAIN IN THE REGION OF TREATMENT. MRI SHOWED A PIECE OF METAL IN THE AREA THAT WAS REMOVED BY A SUBSEQUENT PROCEDURE. IT IS POSSIBLE THAT TREATMENT WITH THE TENEX MICROTIP HAD LEFT A METAL FRAGMENT IN THE TREATMENT AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2295632 TX SYSTEM - TX2 MICROTIP INSTRUMENT, ULTRASONIC SURGICAL LFL TENEX HEALTH, INC. 554-2003-001 2062301 00857156006154

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Other