BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX INFLATABLE BONE TAMP

    MDR report key: 1504658 · Received October 13, 2009

    Report

    Report Number
    2953769-2009-00152
    Event Type
    Injury
    Date Received
    October 13, 2009
    Date of Event
    September 16, 2009
    Report Date
    September 16, 2009
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    HXG
    PMA / PMN Number
    K981251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: ARTICLE TITLED: "BALLOON-RELATED COMPLICATIONS AND TECHNICAL FAILURES IN KYPHOPLASTY FOR VERTEBRAL FRACTURES", BY G. SALIOU, D.R. RUTGERS, E.M. KOCHEIDA, G. LANGMAN, A. MEURIN, H. DERAMOND, P. LEHMANN. DEVICE NOT RETURNED, INTERNAL REVIEW OF LITERATURE.

    Description of Event or Problem · 1

    IN AN ARTICLE TITLED "BALLOON-RELATED COMPLICATIONS AND TECHNICAL FAILURES IN KYPHOPLASTY FOR VERTEBRAL FRACTURES" THE FOLLOWING EVENTS WERE REPORTED: IN THE RETROSPECTIVE REVIEW CONDUCTED AT A SINGLE CENTER, FIFTY-ONE PATIENTS WERE TREATED BY BALLOON KYPHOPLASTY AT 75 SPINAL LEVELS, AND 137 VERTEBROPLASTIES WERE ALSO PERFORMED. FOUR OF THE PATIENTS TREATED WITH BALLOON KYPHOPLASTY EXPERIENCED CORTICAL OR ENDPLATE FRACTURE BY BALLOON EXPANSION AND THREE OF THE PATIENTS HAVING OSTEOPOROSIS AND ONE PATIENT HAVING MYELOMA. IN ONE FEMALE PATIENT (WITH MYELOMA), THE ENDPLATE FRACTURE BY BALLOON EXPANSION LED TO A PROCEDURAL FRACTURE OF AN ADJACENT VERTEBRAL BODY. ADDITIONALLY, FURTHER INFORMATION REPORTED FOR THE BALLOON KYPHOPLASTY PATIENTS INCLUDED 5 BALLOON RUPTURES, LOSS OF FRACTURE REDUCTION IN 4 PATIENTS AFTER BALLOON DEFLATION AND TRANSIENT HYPERALGIA IN 11 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHX INFLATABLE BONE TAMP INFLATABLE BONE TAMP HXG MEDTRONIC SPINE LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other