BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX® HV-R¿ BONE CEMENT

    MDR report key: 1920318 · Received December 10, 2010

    Report

    Report Number
    2953769-2010-00598
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    MEDTRONIC SPINE LLC
    Product Code
    NDN
    PMA / PMN Number
    K041584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: ARTICLE TITLED "VERTEBRAL AUGMENTATION: 7 YEARS EXPERIENCE", BY GIOVANNI CARLO ANSELMETTI, GIUSEPPE BONALDI, PAOLO CARPEGGIANI, LUIGI MANFRE, SALVATORE MASALA, AND MARIO MUTO. DEVICE NOT RETURNED; FOLLOWED UP WITH AUTHOR.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED "VERTEBRAL AUGMENTATION: 7 YEARS EXPERIENCE", THE FOLLOWING WAS REPORTED: ON FOLLOW-UP WE OBSERVED 12 OUT OF A GROUP OF 610 PATIENTS TREATED WITH PERCUTANEOUS AUGMENTATION, WHO PRESENTED RECURRENT PAIN RELATED TO NEW FRACTURES OF THE TREATED VERTEBRAL BODY. THE UNDERLYING PATHOLOGY WAS OSTEOPOROSIS IN 11 CASES AND MYELOMA IN ONE CASE. ELEVEN PATIENTS HAD BEEN TREATED WITH PERCUTANEOUS VERTEBROPLASTY (PV) AND ONE WITH KYPHOPLASTY. NOTEWORTHY, A CLEFT WAS PRESENT AT THE TIME OF TREATMENT AND OSTEONECROSIS WAS HISTOLOGICALLY DOCUMENTED IN TEN CASES TREATED BY PV AND IN THE SINGLE CASE TREATED BY KYPHOPLASTY. ALL 12 PATIENTS REPORTED PAIN RELIEF AFTER FIRST TREATMENT BUT INTENSE PAIN RETURNED TO THE ORIGINAL LOCATION VERY SOON AFTER 2-5 DAYS IN SEVEN PATIENTS AND LATER AFTER 1-7 MONTHS IN THE REMAINING FOUR PATIENTS. -ONLY IN ONE CASE THE PAIN RESTARTED AFTER A TRAUMA. IN THE OTHERS IT BEGAN SPONTANEOUSLY. RADIOLOGICAL WORK-UP WAS PERFORMED WITH CT AND MRI AND REVEALED ADDITIONAL VERTEBRAL HEIGHT LOSS IN 7 PATIENTS AND TRUE FRACTURE WITH BONE OR CEMENT FRAGMENTATION IN FOUR PATIENTS. -IN TWO PATIENTS A THIN LIQUID COLLECTION AROUND THE CEMENT WAS NOTED. -EIGHT PATIENTS WERE TREATED CONSERVATIVELY WITH BRACE AND ANALGESIC DRUGS, OBTAINING PAIN REMISSION WITHIN 3 MONTHS. IN FOUR CASES PV WAS REPEATED TO OBTAIN COMPLETE FILLING OF REMNANT VERTEBRAL BODY, WITH SUCCESSFUL PAIN RELIEF. ONLY ONE PATIENT REQUIRED SURGERY DUE TO SPINE INSTABILITY (PGS 154-155). PER THE AUTHOR, THE CEMENT USED IN THE KYPHOPLASTY CASE WAS HV-R. IN THIS CASE, A JUNCTIONAL FRACTURE OF L1 OCCURRED 1 WEEK AFTER POSTERIOR ARTHRODESIS L2-L5. BIOPSY REVEALED ASEPTIC OSTEONECROSIS AND IT WAS TREATED BY KYPHOPLASTY. T11 AND T12 WERE ALSO TREATED PREVENTIVELY BY VERTEBROPLASTY. L1 REFRACTURED AFTER 1 MONTH. IT WAS SURGICALLY DECOMPRESSED AND STABILIZED. OTHER CASES OF REFRACTURE AFTER TREATMENT WITH VERTEBROPLASTY USED OTHER TYPES OF CEMENTS, NOT HV-R. NO FURTHER INFORMATION WAS REPORTED.

    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 Required Intervention