BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TX SYSTEM - TX2 MICROTIP

    MDR report key: 24749864 · Received March 31, 2026

    Report

    Report Number
    1000135560-2026-00011
    Event Type
    Injury
    Date Received
    March 31, 2026
    Date of Event
    January 21, 2026
    Report Date
    March 31, 2026
    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
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ISSUE WAS INITIALLY REPORTED TO FDA MEDWATCH UNDER REPORT NUMBER: MW5183159, WHO THEN REPORTED TO THE MANUFACTURER. THE DEVICE MODEL WAS NOT REPORTED. THE PART NUMBER WAS ENTERED AS 554-2003-001 ON THIS FORM 3500A BASED ON THE REPORTED ANATOMICAL AREA THE PROCEDURE WAS PERFORMED (KNEE). IT IS POSSIBLE THAT A DIFFERENT DEVICE MODEL WAS USED.

    Description of Event or Problem · 0

    A PATIENT REPORTED TO THE FDA MEDWATCH PROGRAM THAT A PORTION OF THE MICROTIP NEEDLE WAS RETAINED IN HIS KNEE FOLLOWING A PROCEDURE WITH THE TENEX SYSTEM. AS A RESULT, HE REQUIRED A REVISION SURGERY AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802666 TX SYSTEM - TX2 MICROTIP INSTRUMENT, ULTRASONIC SURGICAL LFL TENEX HEALTH, INC. 554-2003-001 00857156006154

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other