BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE CLAMP, TITANIUM

    MDR report key: 3972138 · Received July 31, 2014

    Report

    Report Number
    1723170-2014-00803
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 4, 2014
    Report Date
    November 9, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K990214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVED WITH THIS CONCERN. DEVICE MANUFACTURE DATE WAS UNAVAILABLE AS NO LOT NUMBER WAS PROVIDED. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    CORRECTION: ON 13-OCT-2015, IT WAS NOTICED THAT A PREVIOUS MDR SUBMISSION CONTAINED INCORRECT INFORMATION WITH REGARDS TO THE COMMON DEVICE NAME, PRODUCT CODE AND/OR PMA/510(K). THIS MDR IS BEING SUBMITTED TO CORRECT THIS INFORMATION. THERE IS NO NEW INFORMATION TO CHANGE THE PATIENT INFORMATION, EVENT DESCRIPTION OR MANUFACTURER NARRATIVE THAT WAS PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT THE SCREW OF THE CLAMP ATTACHMENT WAS WORN. THERE WAS NO PATIENT INVOLVED WITH THIS CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447872 OPEN SPINE CLAMP, TITANIUM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1