BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 1757305 · Received June 18, 2010

    Report

    Report Number
    2953769-2010-00214
    Event Type
    Malfunction
    Date Received
    June 18, 2010
    Date of Event
    May 9, 2010
    Report Date
    May 27, 2010
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    NDN
    PMA / PMN Number
    K041584
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: ARTICLE TITLED, "PERCUTANEOUS KYPHOPLASTY AND PEDICLE SCREW FIXATION FOR THE MANAGEMENT OF THORACO-LUMBAR BURST FRACTURES" BY STEPHANE FUENTES, BENJAMIN BLONDEL, PHILIPPE METELLUS, JEAN GAUDART, TAREK ADETCHESSI, HENRY DUFOUR. METHOD - DEVICE NOT RETURNED; FOLLOWED UP WITH AUTHOR.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED "PERCUTANEOUS KYPHOPLASTY AND PEDICLE SCREW FIXATION FOR THE MANAGEMENT OF THORACO-LUMBAR BURST FRACTURES", THE FOLLOWING EVENTS WERE REPORTED: IN EIGHTEEN PATIENTS, "A PERCUTANEOUS APPROACH WAS SYSTEMATICALLY USED AND A BALLOON KYPHOPLASTY PROCEDURE WAS PERFORMED VIA THE TRANSPEDICULAR PATHWAY ASSOCIATED WITH PERCUTANEOUS SHORT-SEGMENT PEDICLE SCREW OSTEOSYNTHESIS." POST-OPERATIVE CT SCAN IMAGES SHOWED TWO CASES OF LATERAL LEAKAGE WITHOUT CLINICAL CONSEQUENCES. IT WAS ALSO NOTED THAT ALL BALLOON KYPHOPLASTY PROCEDURES WERE PERFORMED WITH THE BONE CEMENT IN THE DOUGHY STATE. REPORTEDLY, THE PATIENT'S PAIN LEVELS IMPROVED SIGNIFICANTLY AFTER THE OPERATION. NO ADDITIONAL INFORMATION WAS REPORTED. MEDTRONIC SPINE LLC WAS NOT ABLE TO CONFIRM THE BONE CEMENT THAT WAS USED IN THE PATIENTS, WAS THE KYPHX HV-R BONE CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHX HV-R BONE CEMENT HIGH VISCOSITY, RADIOPAQUE BONE CEMENT NDN MEDTRONIC SPINE LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR