BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENEX HEALTH TX SYSTEM - WITH TXB MICROTIP

    MDR report key: 10989506 · Received December 11, 2020

    Report

    Report Number
    1000135560-2020-00053
    Event Type
    Injury
    Date Received
    December 11, 2020
    Date of Event
    September 23, 2020
    Report Date
    March 24, 2021
    Manufacturer
    TENEX HEALTH, INC.
    Product Code
    LFL
    UDI-DI
    00857156006093
    PMA / PMN Number
    K181367
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455308 TENEX HEALTH TX SYSTEM - WITH TXB MICROTIP INSTRUMENT, ULTRASONIC SURGICAL LFL TENEX HEALTH, INC. 554-3003-001 NI 00857156006093

    Patients

    Seq Age Sex Outcome Treatment
    1 Other