BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIDENCE KIT, NO NEEDLES

    MDR report key: 4193409 · Received October 22, 2014

    Report

    Report Number
    1526439-2014-12022
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 25, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NDN
    PMA / PMN Number
    PK060300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNATIONAL AFFILIATE REPORTS LEAKAGE OF THE CONFIDENCE KIT¿S PUMP. CEMENT APPLICATION WAS NOT POSSIBLE. A SUBSTITUTE CONFIDENCE KIT WAS USED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO RESULTING DELAY. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE LOT CODE IS UNKNOWN. A REVIEW OF THE COMPLAINT TREND ANALYSIS WAS PERFORMED AND NO SYSTEMIC TREND WAS IDENTIFIED AS A RESULT OF THE ANALYSIS. WITHOUT THE RETURN OF THE CONFIDENCE KIT, WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. AS NO SYSTEMIC TRENDS HAVE BEEN OBSERVED, THIS COMPLAINT FILE 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS LEAKAGE OF THE CONFIDENCE KIT¿S PUMP. CEMENT APPLICATION WAS NOT POSSIBLE. A SUBSTITUTE CONFIDENCE KIT WAS USED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO RESULTING DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670820 CONFIDENCE KIT, NO NEEDLES CEMENT, BONE, VERTEBROPLASTY NDN DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1