BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLAMP

    MDR report key: 8698664 · Received June 14, 2019

    Report

    Report Number
    1723170-2019-03322
    Event Type
    Malfunction
    Date Received
    June 14, 2019
    Report Date
    June 14, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    OLO
    PMA / PMN Number
    K131425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE 961-578 FOUND A DAMAGED TOOL. THE CLAMP WAS FUNCTIONAL BUT HAD TOOL MARKS ON THE HEAD OF THE ADJUSTMENT SCREW. 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 WHILE OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE MEDIUM SURETRACK CLAMP HAD A STRIPPED SCREW. THERE WAS NO PATIENT PRESENT WHEN THE ISSUE OCCURRED. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495221 CLAMP ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC 961-578 150317

    Patients

    Seq Age Sex Outcome Treatment
    1