BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSCOPE

    MDR report key: 3113766 · Received May 15, 2013

    Report

    Report Number
    2953769-2013-00072
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    HRX
    PMA / PMN Number
    K981251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT ANALYSIS: COMPLAINT RETURN IBT PARTIALLY INFLATED AS RECEIVED. WHEN DEFLATED, THE BALLOON DID NOT FULLY COLLAPSE, PREVENTING THE BALLOON FROM STARTING INTO THE STYLUS CANNULA. UNABLE TO DETERMINE ROOT CAUSE OF THE FOREGOING EVENT FROM THE AVAILABLE INFORMATION. THE IBT WAS RECEIVED IN A CONDITION UNSUITABLE FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BALLOON KYPHOPLASTY PROCEDURE (BKP) AND DURING THE PROCEDURE, "THE BALLOONS WOULD NOT ADVANCE DOWN THE CANNULA". A NEW KIT WAS OPENED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214161 ARTHROSCOPE HRX MDT KYPHON NEUCHATEL MFG NA 0006601313

    Patients

    Seq Age Sex Outcome Treatment
    1 CANNULA