BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSCOPE

    MDR report key: 2904927 · Received January 9, 2013

    Report

    Report Number
    1030489-2013-00101
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 10, 2012
    Report Date
    July 24, 2013
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    HRX
    PMA / PMN Number
    K981251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: VISUAL REVIEW DID NOT IDENTIFY MATERIAL DAMAGE. WHEN ATTEMPTING TO EVACUATE THE BALLOON THE BALLOON DID NOT FULLY COLLAPSE, OR COLLAPSE CONSISTENT WITH ORIGINAL (PRE-INFLATION) GEOMETRY, PREVENTING THE BALLOON FROM STARTING INTO THE STYLUS CANNULA. UNABLE TO EVALUATE THE INSTRUMENT AS RECEIVED. UNABLE TO DETERMINE ROOT CAUSE OF THE FOREGOING EVENT FROM THE AVAILABLE INFORMATION. THE IBT¿S WERE RECEIVED IN A CONDITION UNSUITABLE FOR ANALYSIS.

    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

    IT WAS REPORTED THAT DURING A BALLOON KYPHOPLASTY PROCEDURE, THE BALLOONS WOULD NOT FIT DOWN THE CANNULA. AN ADDITIONAL KIT WAS OPENED AND THE BALLOONS FROM THAT KIT ADVANCED DOWN THE CANNULA WITH NO PROBLEMS. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11200 ARTHROSCOPE HRX MDT KYPHON NEUCHATEL MFG NA 0006517833

    Patients

    Seq Age Sex Outcome Treatment
    1 CANNULA