BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSCOPE

    MDR report key: 3973366 · Received August 1, 2014

    Report

    Report Number
    2953769-2014-00102
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    HRX
    PMA / PMN Number
    K041454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    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. DEVICES OF MULTIPLE PART/LOT NUMBERS WERE USED DURING THE PROCEDURE INCLUDING: PART: K15B / LOT: 0006915337 / MANUF DATE: 24 OCT. 2013 PART: K15B / LOT: 0006910715 / MANUF DATE: 23 OCT. 2013. ALTHOUGH IT IS UNKNOWN WHICH OF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BALLOON KYPHOPLASTY PROCEDURE (BKP) AT T11 AND T12. DURING THE PROCEDURE, ONE OF THE BALLOONS WAS INFLATED TO APPROXIMATELY 200 PSI WITH 2.5CC VOLUME WHEN IT RUPTURED. THE BALLOON WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS WAS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451056 ARTHROSCOPE HRX MDT KYPHON NEUCHATEL MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1