BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISUALASE

    MDR report key: 23427239 · Received October 30, 2025

    Report

    Report Number
    1723170-2025-03598
    Event Type
    Malfunction
    Date Received
    October 30, 2025
    Date of Event
    August 26, 2025
    Report Date
    October 30, 2025
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    GAH
    UDI-DI
    00763000416461
    PMA / PMN Number
    K081656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE RETURNED BONE ANCHOR WAS CRACKED. CODES B01, C07, AND D02 ARE APPLICABLE. 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 A THERMAL THERAPY SYSTEM. IT WAS REPORTED THAT THE TITANIUM BONE ANCHOR HAD A CRACK IN IT. THE SITE OPENED THE KIT IN THE STERILE FIELD AND NOTICED THE CRACK BEFORE USE. THERE WAS NO DELAY AND NO IMPACT ON THE PATIENT'S OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1341943 VISUALASE STYLET, SURGICAL, GENERAL & PLASTIC SURGERY GAH MEDTRONIC NAVIGATION, INC. 9735571 2025010024 00763000416461

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female