BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NAVIGATION, INC

    MDR report key: 19133376 · Received April 18, 2024

    Report

    Report Number
    1723170-2024-01100
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    April 15, 2024
    Report Date
    April 18, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    MAX
    UDI-DI
    00613994151179
    PMA / PMN Number
    K131425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.  CODES: B17, C20, D15 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING AN IMAGING SYSTEM BEING USED INTRA-OPERATIVELY DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SMALL SPINE FRAME WAS FOUND TO BE LOOSE AFTER NAVIGATING PROBE AND NOTICING INACCURATE ANATOMY. A NEW TRAY WAS OPENED, A DIFFERENT FRAME WAS ATTACHED TO PERCUTANEOUS PIN, AND THE TEAM TOOK A NEW SPIN WITH NO FURTHER ACCURACY OR FRAME COMPLICATIONS. THE FIELD REPRESENTATIVE (REP) REPORTED THE SPRING ON THE FRAME SEEMED LOOSE, AS WELL AS TEETH VERY WORN DOWN, ALLOWING FRAME TO ROTATE EASILY AND MOVE BACK AND FORTH WITH LITTLE FORCE. PATIENT PRESENT. 5 MIN DELAY. NO KNOWN IMPACT TO PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2287936 MEDTRONIC NAVIGATION, INC INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX MEDTRONIC NAVIGATION, INC 9732353 120813 00613994151179

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female SEE H11...