BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFLATABLE BONE TAMP

    MDR report key: 375402 · Received February 1, 2002

    Report

    Report Number
    2953769-2002-00001
    Event Type
    Injury
    Date Received
    February 1, 2002
    Date of Event
    January 3, 2002
    Report Date
    January 31, 2002
    Manufacturer
    KYPHON INC.
    Product Code
    HXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DISTAL TIP OF THE INFLATABLE BONE TAMP BROKE OFF FROM THE CATHETER DURING SURGERY. DOCTOR USED ADDITIONAL INTERVERNTION (FORCEPS) TO RETRIEVE THE TAMP FROM THE VERTEBRAL BODY. NO MAJOR DELAY IN SURGERY WAS NOTED. NO PATIENT COMPLICATIONS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFLATABLE BONE TAMP TAMP HXG KYPHON INC. NA 01101908

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention