BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIDENCE SPINAL CEMENT SYSTEM WITH NO NEEDLES

    MDR report key: 1761093 · Received July 14, 2010

    Report

    Report Number
    1526439-2010-00100
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Date of Event
    June 17, 2010
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    NDN
    PMA / PMN Number
    K060300
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY SPINE HAS REQUESTED THE RETURN OF THE DEVICE. A F/U MEDWATCH REPORT WILL BE FILED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE EVAL.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS LEAKAGE OCCURRED IN THE TUBING CONNECTION OF THE PUMP. ANOTHER KIT WAS ON HAND TO COMPLETE THE PROCEDURE. HOWEVER, IT IS REPORTED THAT THE DIFFICULTY RESULTED IN A DELAY OF SIXTY MINUTES DURING WHICH TIME THE PATIENT WAS UNDER ANESTHESIA. THERE WERE NO FURTHER COMPLICATIONS AND NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONFIDENCE SPINAL CEMENT SYSTEM WITH NO NEEDLES CEMENT, BONE, VERTEBROPLASTY NDN DEPUY SPINE, INC. NA HKJBK8

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK