BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20/3 KYPHON XPANDER II EU

    MDR report key: 3230049 · Received July 16, 2013

    Report

    Report Number
    2953769-2013-00107
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 14, 2013
    Report Date
    July 8, 2013
    Manufacturer
    KYPHON NEUCHATEL
    Product Code
    HRX
    PMA / PMN Number
    K981251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PRODUCT WAS RECEIVED. VISUAL ANALYSIS HAS BEEN PERFORMED AND DOES NOT INDICATE ANY DAMAGE OR ISSUE. FUNCTIONAL ANALYSIS HAS BEEN DONE AND CONFIRMED THAT THIS IBT IS WORKING PROPERLY. NO LEAKAGE OBSERVED. BASED ON THE INFORMATION PROVIDED, VISUAL AND FUNCTIONAL ANALYSIS THIS IBT DOES NOT PRESENT ANY DAMAGE OR LEAKAGE AND IT IS WORKING AS INTENDED. COMPLAINT NOT CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN KYPHOPLASTY PROCEDURE. DURING THE PROCEDURE, THE BALLOON RUPTURED AND THE CONTRAST MEDIA LEAKED. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328689 20/3 KYPHON XPANDER II EU ARTHROSCOPE HRX KYPHON NEUCHATEL 0006612423

    Patients

    Seq Age Sex Outcome Treatment
    1