BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIDENCE KIT, NO NEEDLES

    MDR report key: 3717972 · Received April 1, 2014

    Report

    Report Number
    1526439-2014-11427
    Event Type
    Malfunction
    Date Received
    April 1, 2014
    Report Date
    March 5, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NDN
    PMA / PMN Number
    PK060300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    510K NUMBER = K060300. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED CONFIDENCE KIT AND ITS PUMP FOUND NO DISCREPANCIES. PRESSURIZATION OF THE PUMP UNTIL THE SAFETY VALVE ENGAGED DID NOT RESULT IN ANY LEAKAGE OF WATER. REVIEWS OF THE DEVICE HISTORY RECORDS FOR THE KIT AND ITS PUMP COMPONENTS FOUND NO DISCREPANCIES. A 12 MONTH COMPLAINT TREND ANALYSIS ON THE PRODUCT FAMILY FOUND NO EMERGING TRENDS. THE ROOT CAUSE FOR THE WATER LEAKING AT THE SIDES OF THE PUMP CANNOT BE POSITIVELY IDENTIFIED BECAUSE THE COMPLAINT COULD NOT BE CONFIRMED. NO CORRECTIVE ACTION/PREVENTIVE ACTION IS REQUIRED AT THIS POINT AS THERE HAS BEEN NO ISSUES IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THIS DEVICE, AND THERE HAVE BEEN NO SYSTEMATIC TREND. THEREFORE, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE CONFIDENCE KIT PUMP WAS LEAKING WATER WHICH WAS SPOUTING AT THE SIDES OF THE DEVICE. THE DIFFICULTY DID NOT RESULT IN ANY DELAY TO THE PROCEDURE AS ANOTHER SYSTEM WAS AVAILABLE FOR USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193587 CONFIDENCE KIT, NO NEEDLES CEMENT, BONE, VERTEBROPLASTY NDN DEPUY SYNTHES SPINE HPMC6V

    Patients

    Seq Age Sex Outcome Treatment
    1