BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE CLAMP, TITANIUM

    MDR report key: 3981991 · Received August 5, 2014

    Report

    Report Number
    1723170-2014-00812
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 8, 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
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVED WITH THIS CONCERN. THREE DEVICES WERE RETURNED AND THE LOT NUMBERS AND ASSOCIATED DEVICE MANUFACTURE DATES ARE AS FOLLOWS: DEVICE #1=LOT# 110317=MFR DATE 03/17/2011; DEVICE#2=LOT# 120313=MFR DATE 03/13/2012; DEVICE #3=LOT# 120612=MFR DATE 06/12/2012. THREE DEVICES WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS AND ALL SHOWED SIGNS OF PHYSICAL DAMAGE. ALL THREE CLAMPS HAD DEBRIS IN THE THREADS OR WERE STRIPPED IN THE MIDDLE OF THE TRAVEL. ALL THREE RETAINER RINGS WERE STRETCHED ALLOWING MOVEMENT OF THE CLAMP FACE. THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY CAUSE WAS FROM OVER TIGHTENING. A SUMMARY OF THE FINDINGS WAS PROVIDED TO THE MEDTRONIC REP. THE SITE CHOSE NOT TO REPLACE THE DEVICES.

    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 MEDTRONIC REPRESENTATIVE REPORTED THAT THEY WERE HAVING ISSUES WITH THE SCREWS OF THE SPINE CLAMPS BECOMING STRIPPED AND THEN FROZEN AND UNUSABLE. THE SITE IS RETURNING THREE CLAMPS THAT ARE UNUSABLE BECAUSE THE SCREWS CANNOT CLAMP DOWN ON THE HEAD AND TIGHTEN THE CLAMP PROPERLY. THERE WAS NO PATIENT INVOLVED WITH THIS CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458081 OPEN SPINE CLAMP, TITANIUM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 110317, 120313, 120612

    Patients

    Seq Age Sex Outcome Treatment
    1