BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSCOPE

    MDR report key: 2992302 · Received March 7, 2013

    Report

    Report Number
    2953769-2013-00039
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 8, 2013
    Report Date
    March 27, 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

    ADDITIONAL INFORMAITON: PRODUCT ANALYSIS: IBT ANALYSIS - COMPLAINT RETURN INFLATABLE BONE TAMP (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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BALLOON KYPHOPLASTY PROCEDURE AT T7. DURING THE PROCEDURE, "THE BALLOON WOULD NOT ADVANCE DOWN THE CANNULA." ACCORDING TO THE REPORT, THE BALLOON WAS NOT INFLATED PRIOR TO TRYING TO ADVANCE IT. THE PROCEDURE WAS DELAYED APPROXIMATELY 10 MINUTES BUT WAS COMPLETED SUCCESSFULLY USING A BALLOON FROM A NEW KIT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97015 ARTHROSCOPE HRX MDT KYPHON NEUCHATEL MFG NA 0006629341

    Patients

    Seq Age Sex Outcome Treatment
    1 CANNULA