BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TXTIHA IBF SYSTEM

    MDR report key: 15879552 · Received November 29, 2022

    Report

    Report Number
    3004719693-2022-00001
    Event Type
    Injury
    Date Received
    November 29, 2022
    Date of Event
    October 20, 2022
    Report Date
    November 22, 2022
    Manufacturer
    INNOVASIS, INC.
    Product Code
    MAX
    UDI-DI
    00+M711LS39509
    PMA / PMN Number
    K180078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PER RISK ASSESSMENT THE FOLLOWING MAY APPLY: "TRIAL IMPLANTED" MAY LEAD TO "FAILED FUSION, IMPLANT MIGRATION, PAIN, SURGICAL DELAY, REVISION SURGERY." "INSTRUMENT BREAKAGE/DAMAGE" MAY LEAD TO "CUSTOMER DISSATISFACTION, SURGICAL DELAY" "OCCURRENCE MAY REQUIRE SUBSEQUENT TREATMENT BUT HAS NO LONG TERM LIFE LIMITING CONSEQUENCES." FOR THIS SPECIFIC CASE, THE ONLY EFFECT ON THE PATIENT THUS FAR HAS BEEN SLIGHT SURGICAL DELAY. [IMPLANTING THE TRIAL IMPLANT IS CONSIDERED OFF-LABEL USE THEREFORE THE SURGEON WILL MONITOR FOR ANY ADVERSE EFFECTS.]

    Description of Event or Problem · 0

    DURING A TLIF PROCEDURE, THE SURGEON IMPACTED A TRIAL IMPLANT INTO THE DISC SPACE FOR SIZING PURPOSES. WHEN ATTEMPTING TO REMOVE THE TRIAL, THE INNER SHAFT OF THE INSERTER BROKE, LEAVING THE TRIAL EMBEDDED IN THE DISC SPACE. THE SURGEON AGAIN ATTEMPTED TO REMOVE THE TRIAL BY OTHER MEANS, BUT WAS UNABLE TO DO SO AND SUBSEQUENTLY DECIDED TO LEAVE IT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2084255 TXTIHA IBF SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX INNOVASIS, INC. LS-395 00+M711LS39509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown