BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TX SYSTEM - TX1 MICROTIP

    MDR report key: 23297041 · Received October 15, 2025

    Report

    Report Number
    1000135560-2025-00036
    Event Type
    Injury
    Date Received
    October 15, 2025
    Report Date
    October 14, 2025
    Manufacturer
    TENEX HEALTH, INC.
    Product Code
    LFL
    UDI-DI
    00857156006215
    PMA / PMN Number
    K123640
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. PICTURES OF THE REMOVED NEEDLE FRAGMENT WERE PROVIDED BY THE REPORTER. IT WAS CONFIRMED THAT THE MICROTIP NEEDLE HAD SEPARATED FROM THE REST OF THE HANDPIECE. THE FRACTURE SITE DID NOT IMMEDIATELY INDICATE A SPECIFIC CAUSE FOR THE FAILURE.

    Description of Event or Problem · 0

    A PATIENT REPORTED PAIN AND OBSERVED A RETAINED PORTION OF THE MICROTIP NEEDLE EMERGING FROM THEIR FOOT 4-6 WEEKS FOLLOWING A PROCEDURE WITH THE TENEX SYSTEM (APPROXIMATELY BETWEEN (B)(6) 2025). PATIENT EXTRACTED THE NEEDLE UNDER DIRECTION FROM THEIR DOCTOR AND IS EXPECTED TO FOLLOW UP WITH THE DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2358447 TX SYSTEM - TX1 MICROTIP INSTRUMENT, ULTRASONIC SURGICAL LFL TENEX HEALTH, INC. 554-1003-001 00857156006215

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other