BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON® EXPRESS¿ INFLATABLE BONE TAMP

    MDR report key: 6517693 · Received April 25, 2017

    Report

    Report Number
    2953769-2017-00046
    Event Type
    Malfunction
    Date Received
    April 25, 2017
    Date of Event
    March 31, 2017
    Report Date
    March 31, 2017
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    HRX
    PMA / PMN Number
    REFER H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR SALE IN THE US BUT A SIMILAR PART WITH CATALOGUE# KE102 AND 510K# K123771 AND (B)(4) IS APPROVED FOR SALE IN THE US. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2017, PATIENT UNDERWENT SURGERY AT LEVEL "D12". INTRA-OP, PRESSURE AUTOMATICALLY WENT TO ZERO, AT THIS MOMENT INFLATED BALLOON WASN'T VISIBLE IN "RX" AND WHEN IT WAS REMOVED, BALLOON RUPTURED. PRODUCT CAME IN CONTACT WITH THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT WAS NOT ALLERGIC TO CONTRAST MEDIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302615 KYPHON® EXPRESS¿ INFLATABLE BONE TAMP ARTHROSCOPE HRX MDT KYPHON NEUCHATEL MFG NA 0008107891

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR