BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHO 1-STEP KIT

    MDR report key: 2471929 · Received February 17, 2012

    Report

    Report Number
    2471929
    Event Type
    Malfunction
    Date Received
    February 17, 2012
    Date of Event
    January 27, 2012
    Report Date
    February 17, 2012
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    HXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE L1 AND L2 PEDICLES WERE CANNULATED. THIS WAS DONE UNDER AP (ANTERIOR-POSTERIOR) AND LATERAL FLUOROSCOPIC GUIDANCE. A DRILL WAS USED AND THE BALLOONS WERE ADVANCED, 1 ON EACH SIDE AND 2 ON EACH VERTEBRA. THEY WERE INFLATED AND THE CEMENT WAS MIXED. ALL THE BALLOONS WERE ABLE TO BE DEFLATED EXCEPT FOR ONE ON THE RIGHT SIDE, WHICH REQUIRED SOME VIGOROUS SUCTION BEFORE IT WAS ABLE TO BE DEFLATED AND PULLED OUT.TWO REPROCESSED AND TWO NEW PIECES WERE OPENED. IT IS UNKNOWN WHICH PRODUCT FAILED TO DEFLATE. SERIAL NUMBER SENT TO MANUFACTURER WITHOUT RETAINING THE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHO 1-STEP KIT INFLATABLE BONE TAMP HXG MEDTRONIC SPINE LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR