BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S8 PREMIUM SYSTEM

    MDR report key: 9889283 · Received March 27, 2020

    Report

    Report Number
    1723170-2020-01091
    Event Type
    Malfunction
    Date Received
    March 27, 2020
    Date of Event
    March 25, 2020
    Report Date
    April 15, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9734252, SERIAL/LOT #: (B)(4), UBD: UNKNOWN, UDI#: UNKNOWN. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    VERTEK ARM WAS RETURNED AND ANALYZED. IT WAS NOTED THAT THE RETURNED VERTEK ARM LOCKS AND RELEASES WITHOUT ISSUE. NO PROBLEM FOUND. LOT NUMBER 2920/111221. METHOD/RESULT/CONCLUSION CODES ARE ASSOCIATED WITH ANALYSIS FOR THE PART THAT WAS RETURNED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE ARTICULATING ARM WOULD NO LONGER TIGHTEN. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351937 STEALTHSTATION S8 PREMIUM SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1