BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 1920379 · Received December 10, 2010

    Report

    Report Number
    2953769-2010-00603
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 19, 2010
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWED UP BY COMPANY REPRESENTATIVE. THIS MDR IS FOR THE CEMENT LEAKAGE. PLEASE REFERENCE MDR FOR 1 BALLOON AND MDR FOR 2ND BALLOON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A KYPHOPLASTY PROCEDURE. DURING THE PROCEDURE, THE TWO BALLOONS BROKE WITH BILATERAL EXTRAVASATION OF THE CONTRAST LIQUID FOLLOWED BY CEMENT LEAKAGE. COULD NOT CONFIRM IF ANY FRAGMENTS OF THE BALLOON WERE LEFT IN THE PATIENT. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHX® HV-R¿ BONE CEMENT CEMENT, BONE, VERTEBROPLASTY NDN MEDTRONIC SPINE LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1