BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSCOPE

    MDR report key: 4121698 · Received September 26, 2014

    Report

    Report Number
    2953769-2014-00121
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 27, 2014
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    HRX
    PMA / PMN Number
    K041454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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.

    Description of Event or Problem · 1

    INITIAL DIAGNOSIS: COMPRESSION FRACTURE IT WAS REPORTED THAT A PATIENT WITH A COMPRESSION FRACTURE UNDERWENT A BKP AT L3. AS THE BALLOON WAS BEING INFLATED, THE PHYSICIAN NOTICED "LEAKAGE OF CONTRAST AGENT". THE CONCERNED BALLOON WAS REMOVED AND WAS REPLACED WITH A NEW BALLOON AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SURGICAL TIME WAS NOT EXTENDED DUE TO THE INCIDENT AND NO BALLOON FRAGMENTS WERE LEFT IN THE PATIENT. NO PATIENT COMPLICATIONS WERE ASSOCIATE WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601697 ARTHROSCOPE HRX MDT KYPHON NEUCHATEL MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 CEMENT, BKP