BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSCOPE

    MDR report key: 2880381 · Received December 19, 2012

    Report

    Report Number
    2953769-2012-00175
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    November 20, 2012
    Report Date
    March 22, 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).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PRODUCT ANALYSIS RESULTS: IBT ANALYSIS - COMPLAINT RETURN IBT PARTIALLY INFLATED AS RECEIVED. WHEN DEFLATED, THE IBT COLLAPSED AXIALLY, BUT NOT TRANSVERSELY (IBT BALLOON WIDTH). AS SUCH, THE BALLOON WAS UNABLE TO BE STARTED 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 AT L1. ONE OF THE BALLOONS FAILED TO ADVANCE DOWN THE WORKING CANNULA DURING THE PROCEDURE AND WHEN ANOTHER KIT WAS OPENED, THE BALLOON FROM THAT KIT WOULD NOT ADVANCE DOWN THE CANNULA EITHER. THIS CAUSED A DELAY WITH THE PROCEDURE OF APPROXIMATELY 10 MINUTES, HOWEVER NO PATIENT COMPLICATIONS WERE REPORTED AND PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROSCOPE HRX MDT KYPHON NEUCHATEL MFG NA 0006343040

    Patients

    Seq Age Sex Outcome Treatment
    1 CANNULA, IBT