BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACC 961-578 SURETRAK2, MEDIUM CLAMP

    MDR report key: 8187382 · Received December 20, 2018

    Report

    Report Number
    1723170-2018-06392
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    November 28, 2018
    Report Date
    December 20, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    OLO
    PMA / PMN Number
    K131425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. UDI NOT AVAILABLE FOR THIS SYSTEM AT TIME OF FILING. THE INSTRUMENT WAS NOT RETURNED, SO NO ANALYSIS WAS CONDUCTED. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. 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 OUTSIDE A PROCEDURE. IT WAS REPORTED THAT THE SCREW OF THE SURETRAK MEDIUM CLAMP COULD NOT BE TIGHTENED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026888 ACC 961-578 SURETRAK2, MEDIUM CLAMP ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC 961-578 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1