BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX HV-R BONE CEMENT

    MDR report key: 728970 · Received June 23, 2006

    Report

    Report Number
    2953769-2006-00034
    Event Type
    Injury
    Date Received
    June 23, 2006
    Date of Event
    May 25, 2006
    Report Date
    May 25, 2006
    Manufacturer
    KYPHON, INC.
    Product Code
    NDN
    PMA / PMN Number
    K033801
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    510(K)# K033801

    Description of Event or Problem · 1

    A BALLOON KYPHOPLASTY PROCEDURE WAS PERFORMED ON A PATIENT APPROXIMATELY ONE YEAR AGO. THE ORIGINAL PROCEDURE WENT WELL, BUT THE BONE CEMENT HARDENED IN THE CANNULA EXTENDING PAST THE PEDICLE INTO THE SURROUNDING SOFT TISSUES. THE SPICULE OF BONE CEMENT WAS NOT REMOVED AT THE COMPLETION OF THE PROCEDURE. THE PATIENT DID NOT COMPLAIN OF PAIN OR DISCOMFORT AT THAT TIME. SUBSEQUENTLY, THE PATIENT DEVELOPED PAIN IN THE AREA OF THE BONE CEMENT AND SURGERY WAS PERFORMED TO REMOVE THE SPICULE OF BONE CEMENT FROM THE SOFT TISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHX HV-R BONE CEMENT HIGH VISCOSITY, RADIOPAQUE BONE CEMENT NDN KYPHON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention