BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KYPHX INFLATABLE BONE TAMP, 20/3

    MDR report key: 516746 · Received March 19, 2004

    Report

    Report Number
    2953769-2004-00002
    Event Type
    Injury
    Date Received
    March 19, 2004
    Date of Event
    February 26, 2004
    Report Date
    February 26, 2004
    Manufacturer
    KYPHON INC.
    Product Code
    HXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PORTION OF THE DISTAL TIP OF THE INFLATABLE BONE TAMP BROKE OFF FROM THE CATHETER DURING SURGERY. SURGEON USED SURGICAL INTERVENTION TO RETRIEVE THE BALLOON FRAGMENT FROM THE VERTEBRAL BODY. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER DIFFICULTY AND THE PT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHX INFLATABLE BONE TAMP, 20/3 TAMP HXG KYPHON INC. NA 03103002

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention