BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACC 960-535 MOUNT DOUBLE STAR ADAPTER

    MDR report key: 8431865 · Received March 19, 2019

    Report

    Report Number
    1723170-2019-01196
    Event Type
    Malfunction
    Date Received
    March 19, 2019
    Date of Event
    February 20, 2019
    Report Date
    June 3, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00681490915939
    PMA / PMN Number
    K954276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADAPTER WAS RETURNED TO THE MANUFACTURER AND ANALYSIS WAS COMPLETED. FUNCTIONAL TESTING AND VISUAL/PHYSICAL EXAMINATION WAS PERFORMED AND NO FAILURE WAS FOUND. THE RETURNED ADAPTER WAS FOUND TO BE IN GOOD CONDITION WITH NO APPARENT PHYSICAL DAMAGE. THE ATTACHMENT SCREW AND THREADS WERE INTACT AND IT WAS POSSIBLE TO MOUNT THE ADAPTER WITHOUT ISSUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE DUE TO LEGAL/CONFIDENTIAL REASONS. THE INSTRUMENT WAS NOT RETURNED, SO NO ANALYSIS WAS CONDUCTED. 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 DEVICE BEING USED FOR A CRANIAL RESECTION PROCEDURE. THE ISSUE OCCURRED PRE-OPERATIVELY AND CAUSED NO DELAY TO THE SURGERY. IT WAS REPORTED THAT THE DUAL STARBURST ATTACHMENT COULD NOT BE FITTED IN WELL. THE SCREW HOLE OF THE ATTACHMENT COULD NOT BE FITTED IN WELL. THE SURGERY WAS COMPLETED WITH NAVIGATION/IMAGING SYSTEM AND BACK UP PRODUCTS. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224883 ACC 960-535 MOUNT DOUBLE STAR ADAPTER INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 960-535 090730 00681490915939

    Patients

    Seq Age Sex Outcome Treatment
    1