BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUALASE

    MDR report key: 16505466 · Received March 8, 2023

    Report

    Report Number
    1723170-2023-00350
    Event Type
    Malfunction
    Date Received
    March 8, 2023
    Date of Event
    March 1, 2023
    Report Date
    March 8, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GAH
    UDI-DI
    00763000416461
    PMA / PMN Number
    K081656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT THE BONE ANCHOR BROKE WHEN IT WAS SCREWED INTO THE SKULL. DURING THE IMPLANTATION OF THE TITANIUM BONE ANCHOR, THE TITANIUM PART OF THE BONE ANCHOR DETACHED FROM THE WHITE PLASTIC PART WITH A SLIGHT ROTATION FORCE APPLIED. THE BONE ANCHOR WAS NOT FULLY INSERTED, THEREFORE, A HIGH FORCE WAS UNLIKELY TO HAVE CAUSED THE DETACHMENT. THE BONE ANCHOR WAS NOT FULLY INSERTED INTO THE BONE, AND THEREFORE THE TITANIUM THREAD COULD BE REMOVED FROM THE BONE WITH A CLAMP. THE BONE ANCHOR WAS REMOVED FROM THE PATIENT. IT BROKE BEFORE IT HAD REACHED ITS FINAL POSITION. A NEW ACCESSORY KIT SET WAS OPENED AND THE NEW BONE ANCHOR WAS USED AND FIT WELL. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125258 VISUALASE STYLET, SURGICAL, GENERAL & PLASTIC SURGERY GAH MEDTRONIC NAVIGATION, INC 9735571 2021100833 00763000416461

    Patients

    Seq Age Sex Outcome Treatment
    1 Male