MAUDE Adverse Event Report: TENEX HEALTH, INC. TX SYSTEM - TX2 MICROTIP; INSTRUMENT, ULTRASONIC SURGICAL

Model Number	554-2003-001
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Neuropathy (1983); Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: TX SYSTEM - TX2 MICROTIP
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): TENEX HEALTH, INC.; 26902 vista terrace; lake forest CA 92630 8123
• Manufacturer (Section G): TENEX HEALTH, INC.; 26902 vista terrace; lake forest CA 92630 8123
• Manufacturer Contact: david vancelette ; 26902 vista terrace; lake forest, CA 92630-8123 ; 9492388220
• MDR Report Key: 24273614
• Report Number: 1000135560-2026-00001
• Device Sequence Number: 10658797
• Product Code: LFL
• UDI-Device Identifier: 00857156006154
• UDI-Public: (01)00857156006154
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K153299
• Number of Events Summarized: 4
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 554-2003-001
• Device Catalogue Number: 554-2003-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown