BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 1626341 · Received February 10, 2010

    Report

    Report Number
    2953769-2010-00029
    Event Type
    Malfunction
    Date Received
    February 10, 2010
    Date of Event
    August 31, 2009
    Report Date
    January 16, 2010
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    NDN
    PMA / PMN Number
    K033801
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: ARTICLE TITLED "CORRELATIVE FACTOR ANALYSIS ON THE COMPLICATIONS RESULTING FROM CEMENT LEAKAGE AFTER PERCUTANEOUS KYPHOPLASTY IN THE TREATMENT OF OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURE" BY HU REN, MOM, YONG SHEN, MD, YING-ZE ZHANG, MD, WEN-YUAN DING, MD, JIA-XIN XU, MOM, DA-LONG YANG, MOM, AND JUN-MING CAO, MD. METHOD; DEVICE NOT RETURNED; FOLLOWED-UP WITH AUTHOR.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED "CORRELATIVE FACTOR ANALYSIS ON THE COMPLICATIONS RESULTING FROM CEMENT LEAKAGE AFTER PERCUTANEOUS KYPHOPLASTY IN THE TREATMENT OF OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURE," THE FOLLOWING EVENT WAS REPORTED: SEVENTY ONE PTS WITH 171 VERTEBRAL COMPRESSION FRACTURES WERE TREATED BY PERCUTANEOUS KYPHOPLASTY. CEMENT LEAKAGE OCCURRED IN 17 OUT OF 171 VERTEBRAL BODIES, INCLUDING 7 PARAVERTEBRAL LEAKS, 6 LEAKS INTO INTERVERTEBRAL SPACE, 3 LEAKS INTO CHANNEL OF NEEDLING INSERTION, AND 1 SPINAL CANAL LEAK. IT WAS NOTED THAT THERE WAS NO EVIDENCE OF RADICULOPATHY OR MYELOPATHY RESULTING FROM CEMENT EXTRAVASATION. NINE RECURRENCES OF VERTEBRAL FRACTURES IN 6 PTS INCLUDING 6 ADJACENT VERTEBRAL BODIES. IT WAS NOTED THAT TO DATE, NOTHING CAN BE ESTABLISHED CONCERNING THE INCREASED RISK OF SUBSEQUENT FRACTURES AS IT IS UNCLEAR SUCH FRACTURES ARE PROCEDURE-RELATED OR PART OF THE NATURAL COURSE OF OSTEOPOROSIS. NO ADDITIONAL INFO WAS REPORTED. NOTE: THIS ARTICLE ORIGINATED FROM (B)(4), HOWEVER, KYPHOPLASTY PRODUCTS ARE NOT DISTRIBUTED IN (B)(4). THE REPORTED FOUR PTS WHO DEVELOPED PULMONARY COMPLICATIONS POSTOPERATIVELY ARE FILED IN MFR REPORTS #2953769-2010-00030, -00031, -00032, AND -00033.

    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 72 YR