BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIDENCE KIT

    MDR report key: 3790274 · Received May 5, 2014

    Report

    Report Number
    1526439-2014-11486
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 9, 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 COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. 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

    (B)(4). 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 THAT AFTER THE CEMENTING OF FOUR SCREWS AND WHEN CEMENTING THE FIFTH SCREW, THE VALVE BETWEEN THE CONFIDENCE KIT¿S PUMP AND THE CEMENT RESERVOIR ¿EXPLODED¿ AND WATER CAME OUT FROM THE DEVICES. CLARIFICATION REVEALED THAT WATER ESCAPED FROM BETWEEN THE CONFIDENCE KIT¿S PUMP¿S RECTUS CONNECTOR AND THE NIPPLE ON THE CEMENT RESERVOIR CAP. AFFILIATE REPORTS THERE WAS NO PROBLEM WITH THE CEMENT THAT WAS BEING APPLIED. ANOTHER KIT WAS ON HAND TO COMPLETE THE PROCEDURE WITH NO DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT. THE CATALOG NUMBER AND LOT NUMBER OF THE CONFIDENCE KIT ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266801 CONFIDENCE KIT CEMENT, BONE, VERTEBROPLASTY NDN DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 HIGH VISCOSITY SPINAL CEMENT, (B)(4)