BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHON INFLATABLE BONE TAMP

    MDR report key: 2162790 · Received July 15, 2011

    Report

    Report Number
    2953769-2011-00086
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    April 19, 2011
    Report Date
    July 1, 2011
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    HRX
    PMA / PMN Number
    K981251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). REPORT SOURCE: ARTICLE TITLED "UNILATERAL EXTRAPEDICULAR VERTEBROPLASTY AND KYPHOPLASTY IN LUMBAR COMPRESSION FRACTURES : TECHNIQ UE, ANATOMY AND PRELIMINARY RESULTS", BY SUNG-MIN CHO, M.D., YONG-SUK NAM, PH.D., BYUNG-MOON CHO, M.D., PH.D., SANG-YOUL LEE, M.D., PH.D., SAE-MOON OH, M.D., PH.D., MOON-KYU KIM, M.D., PH.D. EVAL METHOD: FOLLOW-UP WITH COMPANY REPRESENTATIVE.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED "UNILATERAL EXTRAPEDICULAR VERTEBROPLASTY AND KYPHOPLASTY IN LUMBAR COMPRESSION FRACTURES : TECHNIQUE, ANATOMY AND PRELIMINARY RESULTS", A RETROSPECTIVE STUDY WAS CONDUCTED ON 55 CONSECUTIVE PATIENTS WHO UNDERWENT PERCUTANEOUS EXTRAPEDICULAR UNILATERAL KYPHOPLASTY OR VERTEBROPLASTY FOR PAINFUL OSTEOPOROTIC VERTEBRAL COMPRESSION FRACTURES AT THE 74 LUMBAR LEVELS BETWEEN (B)(6) 2006 AND (B)(6) 2009. THE FOLLOWING EVENTS WERE REPORTED. -EPIDURAL CEMENT LEAKAGE INTO NEURAL CANAL WAS NOTED IN 3 KYPHOPLASTY CASES (4.1%) BY POSTOPERATIVE PLAIN RADIOGRAPHY, BUT THERE WERE NO NEUROLOGICAL DEFICITS. -ONE CASE (1.4%) OF RETROPERITONEAL HEMORRHAGE OCCURRED AFTER KYPHOPLASTY DUE TO KIDNEY INJURY. NO FURTHER INFORMATION WAS REPORTED. NOTE: THIS STUDY WAS APPROVED BY THE INSTITUTIONAL REVIEW BOARD OF (B)(6) UNIVERSITY COLLEGE OF MEDICINE IN (B)(6). KYPHOPLASTY PRODUCTS ARE NOT APPROVED FOR DISTRIBUTION IN (B)(6). CEMENT USED IN THIS STUDY WAS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHON INFLATABLE BONE TAMP ARTHROSCOPE HRX MEDTRONIC SPINE LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Other