FDA Adverse Event Injury Summary report: Y

TX SYSTEM - TX2 MICROTIP

MDR report key: 24273614 · Received February 5, 2026

Report

Report Number: 1000135560-2026-00001
Event Type: Injury
Date Received: February 5, 2026
Report Date: February 5, 2026
Manufacturer: TENEX HEALTH, INC.
Product Code: LFL
UDI-DI: 00857156006154
PMA / PMN Number: K153299
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

THE DEVICE PART NUMBER OR MODEL NAME WERE NOT REPORTED / IDENTIFIED IN THE ARTICLE. A PART NUMBER FOR A SPECIFIC INSTRUMENT SET WAS ENTERED AS 554-2003-001 ON THIS FORM 3500A BASED ON THE PROCEDURE REPORTED (PLANTAR FASCIOTOMY). IT IS POSSIBLE THAT A DIFFERENT INSTRUMENT WAS USED. NOTE: DATE OF OCCURENCE COULD NOT BE IDENTIFIED OR ESTIMATED AS THE ARTICLE IS A RETROSPECTIVE REVIEW WITH DATA COLLECTED BETWEEN JANUARY 2020 TO DECEMBER 2022.

Description of Event or Problem · 0

IN THE ARTICLE "MINIMALLY INVASIVE ULTRASOUND-GUIDED PERCUTANEOUS PLANTAR FASCIOTOMY ON CHRONIC PLANTAR FASCIITIS: A RETROSPECTIVE ANALYSIS" BY ENCINAS ET AL., 2 CASES OF DELAYED WOUND HEALING AND 2 CASES OF BAXTER'S NERVE ENTRAPMENT WERE REPORTED IN PATIENTS WHO UNDERWENT A PLANTAR FASCIITIS PROCEDURE WITH THE TX SYSTEM. ALL 4 ADVERSE EVENTS REQUIRED ADDITIONAL INTERVENTION TO TREAT. PATIENTS WITH DELAYED WOUND HEALING WERE TREATED WITH LOCAL WOUND CARE AND ORAL ANTIBIOTICS. PATIENTS WITH BAXTER'S NERVE ENTRAPMENT UNDERWENT BAXTER'S NERVE DECOMPRESSION, WHICH WAS PERFORMED MORE THAN A YEAR AFTER THE INITIAL TX SYSTEM PROCEDURE. THESE ADVERSE EVENTS ARE SUMMARIZED IN THIS FORM 3500A.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
329269	TX SYSTEM - TX2 MICROTIP	INSTRUMENT, ULTRASONIC SURGICAL	LFL	TENEX HEALTH, INC.	554-2003-001	NA	00857156006154

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Other\| R