BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIDENCE SPINAL CEMENT SYSTEM, 11C

    MDR report key: 3863813 · Received June 10, 2014

    Report

    Report Number
    1526439-2014-11605
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 22, 2014
    Report Date
    May 16, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NDN
    PMA / PMN Number
    PK060300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONFIDENCE 11CC SPINAL CEMENT SYSTEM WAS NOT RETURNED FOR EVALUATION. HOWEVER, BASED ON THE COMPLAINT WHAT MOST LIKELY HAPPENED WAS THAT THE SURGEON CONNECTED THE CAP TO THE RESERVOIR BEFORE TRANSFERRING CEMENT, WHICH WOULD CAUSE THE PLUNGER TO BE IN THE EMPTY CEMENT RESERVOIR. THIS WOULD PREVENT THE RESERVOIR FROM BEING LOADED CORRECTLY AND A NEW SET WOULD HAVE TO BE USED IN ORDER TO CORRECTLY APPLY CEMENT. 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 REVIEW OF THE COMPLAINT TREND ANALYSIS FOR THE CONFIDENCE SYSTEM WAS CONDUCTED ON THE FAMILY. THIS ANALYSIS FOUND NO EMERGING TRENDS. 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.

    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.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE CONFIDENCE KIT PRESENTED A PROBLEM DURING THE PROCEDURE. REPORTS THE APPLICATOR OF CEMENT (WHICH IS ATTACHED TO THE NEEDLE) WAS LOOSE PLUNGER. WHILE PLACING THE CEMENT, THE PLUNGER (BLACK END) CLOSED THE OUTPUT OF CEMENT, PREVENTING THE USE. THREE REQUESTS HAVE BEEN MADE TO THE AFFILIATE FOR ADDITIONAL INFORMATION AND CLARIFICATION. TO DATE, THE REQUESTED INFORMATION HAS NOT BEEN PROVIDED. IT IS NOT KNOWN IF ANOTHER KIT WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT ANY ADVERSE CONSEQUENCES TO THE PATIENT OR IF THE DIFFICULTY RESULTED IN A SIGNIFICANT DELAY TO THE PROCEDURE. AS A RESULT OF THE LACK OF INFORMATION THAT HAS BEEN PROVIDED, A MEDWATCH REPORT IS BEING SUBMITTED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339158 CONFIDENCE SPINAL CEMENT SYSTEM, 11C CEMENT, BONE, VERTEBROPLASTY NDN DEPUY SYNTHES SPINE HPJBLM

    Patients

    Seq Age Sex Outcome Treatment
    1