BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE CLAMP, TITANIUM

    MDR report key: 4203598 · Received October 27, 2014

    Report

    Report Number
    1723170-2014-01148
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 29, 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
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER AND DEVICE MANUFACTURE DATE PROVIDED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS AND SHOWED SIGNS OF PHYSICAL DAMAGE. AS REPORTED, THE ATTACHMENT SCREW THREADS WERE STRIPPED IN THE MIDDLE OF THE TRAVEL WITH DEBRIS IN THE THREADS. THE RETAINER RING AT THE TIP OF THE SCREW WAS STRETCHED ALLOWING SOME PLAY IN THE CLAMP FACE. THE HEAD OF THE SCREW WAS NORMAL. THE MOST LIKELY CAUSE OF THE REPORT WAS OVER-TORQUING THE DEVICE DURING USE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE.

    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.

    Additional Manufacturer Narrative · 1

    DEVICE LOT NUMBER, OR SERIAL NUMBER, NOT AVAILABLE. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. NO PARTS HAVE BEEN RETURNED TO MANUFACTURER FOR ANALYSIS.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, A SITE OPEN SPINE CLAMP WAS TIGHTENED SO HARD, USING A DRIVER, THAT IT COULD NOT BE SECURED TIGHT ENOUGH ONTO THE SPINOUS PROCESS. THE SURGEON CONTINUED THE PROCEDURE USING A DIFFERENT INSTRUMENT, A THORACIC CLAMP. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681751 OPEN SPINE CLAMP, TITANIUM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. 131011

    Patients

    Seq Age Sex Outcome Treatment
    1