BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIDENCE KIT, NO NEEDLES

    MDR report key: 3934016 · Received July 15, 2014

    Report

    Report Number
    1526439-2014-11684
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Report Date
    June 20, 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

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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.

    Additional Manufacturer Narrative · 1

    THE CONFIDENCE KIT, NO NEEDLES WAS RETURNED FOR EVALUATION. A FUNCTIONAL TEST WAS CONDUCTED ON THE RETURNED COMPONENTS. THIS EVALUATION CONCLUDED THAT THE SAFETY VALVE ACTIVATED AND NO LEAKS WERE OBSERVED IN THE SYSTEM. THE DEVICE HISTORY RECORD (DHR) AND TRENDING RESULTS HAVE BEEN PROVIDED IN THE FIRST FOLLOW UP ASSOCIATED WITH MANUFACTURER REPORT NUMBER 1526439-2014-11684. THE ROOT CAUSE FOR THE WATER LEAKAGE CANNOT BE DETERMINED BECAUSE NO PRODUCT PROBLEM COULD BE IDENTIFIED. 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

    THE CONFIDENCE KIT, NO NEEDLES WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A 12 MONTH COMPLAINT TREND ANALYSIS FOR THE CONFIDENCE KIT, NO NEEDLES [PRODUCT CODE: 2839-13-000, LOT NO: HRCDG6] LEAKING WAS CONDUCTED ON THE FAMILY, AS THIS FAILURE MODE IS NOT SPECIFIC TO THIS PRODUCT CODE. THIS ANALYSIS FOUND NO SYSTEMIC TRENDS THAT REQUIRE FURTHER ACTION. THE ROOT CAUSE FOR THE WATER LEAKAGE CANNOT BE DETERMINED BECAUSE NO SAMPLE WAS RECEIVED TO INVESTIGATE. 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. NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE CONFIDENCE KIT'S HYDRAULIC PUMP LEAKED WATER DURING CEMENT APPLICATION. A NEW SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO RESULTING DELAY TO THE PROCEDURE AND NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412606 CONFIDENCE KIT, NO NEEDLES CEMENT, BONE, VERTEBROPLASTY NDN DEPUY SYNTHES SPINE HRCDG6

    Patients

    Seq Age Sex Outcome Treatment
    1