BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TX1 TISSUE REMOVAL SYSTEM - MICROTIP

    MDR report key: 10286316 · Received July 16, 2020

    Report

    Report Number
    1000135560-2020-00031
    Event Type
    Injury
    Date Received
    July 16, 2020
    Date of Event
    February 6, 2020
    Report Date
    July 20, 2020
    Manufacturer
    TENEX HEALTH, INC.
    Product Code
    LFL
    PMA / PMN Number
    K123640
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP REPORT #01. FIELDS B4, G7, H2, H6 AND H10 UPDATED. OUR COMPANY CHIEF MEDICAL OFFICER INVESTIGATED THE REPORT AND ADVERSE EVENT WITH THE PATIENT AND PARTICIPATING PHYSICIANS, AND REVIEWED PATIENT X-RAYS. NO DEVICE OR PROCEDURE ISSUES WERE IDENTIFIED OR SUSPECTED. HE FURTHER REVIEWED THE ORTHOPAEDIC LITERATURE FOR ADDITIONAL INFORMATION. NO SIMILAR CASE WAS IDENTIFIED. HE THEN REVIEWED THE CASE WITH EXPERIENCED ELBOW SURGEONS. THEY HAD NOT HEARD OF SUCH AN ISSUE AND COULD NOT CONCEIVE OF SUCH RESULTING FROM A PERCUTANEOUS PROCEDURE SUCH AS THAT PERFORMED WITH THE TENEX HEALTH DEVICE. WE THEREFORE CONCLUDE THAT THE REPORTED PATIENT INJURY IS NOT RELATED TO THE PROCEDURE WITH THE TENEX HEALTH DEVICES.

    Additional Manufacturer Narrative · 1

    A PATIENT CONTACTED TENEX HEALTH TO REPORT PAIN, DELAYED HEALING AND MOBILITY LIMITATIONS FOLLOWING A PROCEDURE WITH A TENEX HEALTH DEVICE. THE SPECIFIC DEVICE WAS NOT IDENTIFIED. IT IS REPORTED ON THIS MDR AS THE TX1 TISSUE REMOVAL SYSTEM - MICROTIP. THE PATIENT HAD A PROCEDURE WITH THE TENEX DEVICE ON HIS LEFT ELBOW/EPICONDYLE IN (B)(6) 2020. HE HAD PREVIOUSLY HAD A PROCEDURE ON HIS RIGHT ELBOW/EPICONDYLE WITH A TENEX DEVICE IN (B)(6) OF 2017. FOLLOWING THE SECOND PROCEDURE, HE EXPERIENCED PAIN AND DELAYED HEALING IN THE LEFT ELBOW AND LIMITED MOBILITY IN BOTH ELBOWS. HE HAS EXPERIENCED DIFFICULTY WITH FLAT HAND USAGE, TURNING HIS ELBOWS BEYOND 60 DEGREES AND ACTIVITIES LIKE BICYCLING AND TYPING. THERE APPEARS TO BE A LOSS OF FOREARM ROTATION (PRONATION). NO SPECIFIC ISSUE WITH A TENEX HEALTH DEVICE OR ITS USE THAT COULD HAVE CAUSED THE PROBLEM WAS IDENTIFIED.

    Description of Event or Problem · 1

    A PATIENT REPORTED POST-PROCEDURAL PAIN, DELAYED HEALING AND FOREARM MOBILITY LIMITATION FOLLOWING A PROCEDURE ON HIS ELBOW/EPICONDYLE WITH A TENEX HEALTH DEVICE. IT IS UNCLEAR IF THE ISSUES WERE RELATED TO TREATMENT WITH THE TENEX HEALTH DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745988 TX1 TISSUE REMOVAL SYSTEM - MICROTIP INSTRUMENT, ULTRASONIC SURGICAL LFL TENEX HEALTH, INC. 554-1003-001 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other