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

Model Number	554-3003-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial mri reading yielded imprecise findings regarding the presence of metallic debris.Secondary review by a mayo clinic musculoskeletal radiologist concluded that metallic detection in the mri was consistent with normal use of metal instruments and did not represent metallic debris.Its presence should not be causing symptoms.
Event or Problem Description
There was a report of patient pain and delayed healing following a procedure with the tx health txb microtip for plantar fasciitis and a calcaneal bone spur.The exact level of patient pain or healing at the time of report, seven weeks after the procedure, was unclear.The patient also had an mri scan five weeks after the procedure that revealed the shallow plantar cavity at the site of the bone spur excision with some accompanying edema.Note: edema is a possible outcome of treatment with the tx system, but is considered a routine response to treatment (as is indicated by a caution statement in the device instructions for use).
Additional Manufacturer Narrative
Further follow-up information was obtained from the reporters.Patient had a follow-up mri scan of the treatment area in (b)(6) 2021.According to physician review, the mri shown significant resolution of the osseous edema.The patient also had a follow-up visit with a physician on (b)(6) 2021 where it was noted that heel pain had been slowly and steadily improving.The patient reported some other foot pain that appeared to be compensatory or associated with stretching and exercises.Overall, improvement is evident clinically and in the imaged bone condition, albeit with prolonged healing.

• Brand Name: TENEX HEALTH TX SYSTEM - WITH TXB MICROTIP
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): TENEX HEALTH, INC.; 26902 vista terrace; lake forest CA 92630 8123
• MDR Report Key: 10989506
• Report Number: 1000135560-2020-00053
• Device Sequence Number: 3548376
• Product Code: LFL
• UDI-Device Identifier: 00857156006093
• UDI-Public: 00857156006093
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K181367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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: 554-3003-001
• Device Catalogue Number: 554-3003-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 12/11/2020
• Supplement Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other