BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 2273183 · Received October 3, 2011

    Report

    Report Number
    2953769-2011-00124
    Event Type
    Malfunction
    Date Received
    October 3, 2011
    Date of Event
    April 12, 2011
    Report Date
    September 8, 2011
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    NDN
    PMA / PMN Number
    K093828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT EVENT: MEAN AGE 58.1 YEARS OLD, RANGE 31-88 YEARS OLD. SEX: 6 MALES, 11 FEMALES. REPORT SOURCE: ARTICLE TITLED "EARLY RESULTS AFTER VERTEBRAL BODY STENTING FOR FRACTURES OF THE ANTERIOR COLUMN OF THE THORACOLUMBAR SPINE", BY ZDENEK KLEZL, HAROON MAJEED, RAJENDRANATH BOMMIREDDY, JOBY JOHN. METHOD: FOLLOW-UP WITH AUTHOR.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED "EARLY RESULTS AFTER VERTEBRAL BODY STENTING FOR FRACTURES OF THE ANTERIOR COLUMN OF THE THORACOLUMBAR SPINE," A STUDY OF 17 PATIENTS WITH 20 VERTEBRAL BODY FRACTURES UNDERWENT VERTEBRAL STENTING (KYPHOPLASTY WITH VERTEBRAL STENTING). THE FOLLOWING WAS REPORTED IN THE RESULTS. -THERE WERE TWO CASES OF INTRAOPERATIVE CEMENT LEAKAGE WHICH DID NOT LEAD TO CLINICALLY SIGNIFICANT CONSEQUENCES. NO FURTHER INFORMATION WAS REPORTED. NOTE: ARTICLE INDICATED RADIO OPAQUE PMMA CEMENT (KYPHX HVR-HIGH VISCOSITY RADIO-OPAQUE, MEDTRONIC, USA) OR CALCIUM PHOSPHATE CEMENT (KYPHON INC., USA) WAS USED IN THE PATIENTS; HOWEVER, DID NOT INDICATE WHICH OF THE BONE CEMENTS (PMMA OR CALCIUM PHOSPHATE) RESULTED IN THE LEAKAGES.

    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 00058 YR