BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TXB TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 10782291 · Received November 3, 2020

    Report

    Report Number
    1000135560-2020-00046
    Event Type
    Injury
    Date Received
    November 3, 2020
    Date of Event
    December 31, 2019
    Report Date
    November 3, 2020
    Manufacturer
    TENEX HEALTH, INC.
    Product Code
    LFL
    UDI-DI
    00857156006093
    PMA / PMN Number
    K181367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN A WEBINAR PRESENTATION, A PHYSICIAN REPORTED A TENDON RUPTURE FOLLOWING A PROCEDURE WITH THE TX SYSTEM. THE PROCEDURE AND RUPTURE WERE OF THE ACHILLES TENDON. THE RUPTURE PRESENTED SIX MONTHS AFTER TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1242585 TXB TISSUE REMOVAL SYSTEM - MICROTIP INSTRUMENT, ULTRASONIC SURGICAL LFL TENEX HEALTH, INC. 554-3003-001 NI 00857156006093

    Patients

    Seq Age Sex Outcome Treatment
    1 Other