BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 1832334 · Received September 3, 2010

    Report

    Report Number
    2953769-2010-00377
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    January 29, 2010
    Report Date
    May 14, 2010
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NDN
    PMA / PMN Number
    K041584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: ARTICLE TITLED "ADJACENT VERTEBRAL FRACTURES AFTER PERCUTANEOUS VERTEBRAL AUGMENTATION OF OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURE: A COMPARISON OF BALLOON KYPHOPLASTY AND VERTEBROPLASTY" BY I. MOVRIN, R. VENGUST, R. KOMADINA. THIS ARTICLE DID NOT INDICATE THE BONE CEMENT USED IN THIS STUDY IS KYPHX HV-R BONE CEMENT. DEVICE NOT RETURNED; FOLLOWED-UP WITH AUTHOR.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED "ADJACENT VERTEBRAL FRACTURES AFTER PERCUTANEOUS VERTEBRAL AUGMENTATION OF OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURE: A COMPARISON OF BALLOON KYPHOPLASTY AND VERTEBROPLASTY", A PROSPECTIVE STUDY OF 46 PTS (51 VERTEBRAL BODIES) UNDERWENT BALLOON KYPHOPLASTY PROCEDURE AND 27 PTS (32 VERTEBRAL BODIES) UNDERWENT VERTEBROPLASTY PROCEDURE WERE PRESENTED. ALL LEVELS TREATED WERE LOCATED IN THE THORACIC AND LUMBAR SPINE. THE FOLLOWING EVENTS WERE REPORTED: THE 65 CEMENT LEAKAGES WERE REPORTED IN THE BALLOON KYPHOPLASTY GROUP. MOST LEAKAGES WERE PARASPINAL (48%), INTRADISCAL (38%, 1 OUT OF 4 PTS), EPIDURAL (11%), PULMONARY (1.5%), AND FORAMINAL (1.5%). THREE PTS OUT OF 7 CASES IN THE VERTEBROPLASTY GROUP HAD INTRADISCAL CEMENT LEAKAGES. ALL LEAKAGES WERE ASYMPTOMATIC AND THERE WAS NO NEED FOR SURGICAL INTERVENTION. IT WAS NOTED THAT THE BONE CEMENT WAS PREPARED AND INJECTED PER IFU. NO ADDITIONAL INFO WAS REPORTED.

    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 60 YR