BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN SPINE CLAMP, TITANIUM

    MDR report key: 6711370 · Received July 13, 2017

    Report

    Report Number
    1723170-2017-02908
    Event Type
    Malfunction
    Date Received
    July 13, 2017
    Date of Event
    June 15, 2017
    Report Date
    March 8, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    UDI-DI
    00643169308879
    PMA / PMN Number
    K990214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. TWO LOT NUMBERS WERE PROVIDED FOR THE SPINE CLAMP 110317, 160406. MANUFACTURE DATE OF LOT 160406 IS 04/06/16. CURRENTLY, CLARIFICATION ON WHICH LOT NUMBER IS THE SUSPECT SPINE CLAMP AND WHICH WAS A SEPARATE PROACTIVE REPLACEMENT IS UNAVAILABLE. ON 6/26/2017 REPLACEMENT PARTS WERE SHIPPED TO SITE. NO PARTS HAVE BEEN RECEIVED BY MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    CORRECTION: LEGAL STATEMENT INADVERTENTLY LEFT OFF OF FOLLOW UP NUMBER 1.

    Additional Manufacturer Narrative · 1

    CORRECTION: PART NUMBER AND UDI WERE INADVERTENTLY PROVIDED INCORRECTLY IN THE INITIAL MDR. CORRECT VALUES ARE NOW PROVIDED IN THE APPROPRIATE FIELDS.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SUSPECT CLAMPS WERE RETURNED TO THE MANUFACTURER AND THE ISSUE CONFIRMED. DURING VISUAL INSPECTION MANY NICKS AND CUTS WERE OBSERVED ON THE CLAMPS. ONE CLAMP WAS A NICK IN THE THREADS OF ONE OF THE ADJUSTMENT SCREWS WHICH CAUSE DIFFICULTY SETTING THE CLAMP. THE OTHER RETURNED CLAMP WAS FULLY FUNCTIONAL. THE HARDWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A HARDWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT DURING A SPINAL FUSION PROCEDURE, THE SPINE CLAMP SCREW HEAD WAS WORN. THE SURGERY WAS COMPLETED WITH THE USE OF ANOTHER CLAMP. THERE WAS A DELAY OF LESS THAN 1 HOUR. NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492048 OPEN SPINE CLAMP, TITANIUM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 110317 00643169308879

    Patients

    Seq Age Sex Outcome Treatment
    1