BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON XPANDER II EU

    MDR report key: 3023088 · Received March 27, 2013

    Report

    Report Number
    2953769-2013-00054
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 25, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    HRX
    PMA / PMN Number
    K981251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT DURING FUNCTIONAL ANALYSIS AN ATTEMPT HAS BEEN DONE TO INFLATE THE BALLOON WITH A LOCKING SYRINGE. THIS INFLATION SHOWS A RUPTURE ON THE BALLOON AND IT WAS NOT POSSIBLE TO INFLATE IT DUE TO THIS LEAKAGE. VISUAL ANALYSIS CONFIRMED THAT THIS BALLOON HAS A RADIAL RUPTURE ON THE DISTAL PEAK. BASED ON THE INFORMATION PROVIDED, FUNCTIONAL AND VISUAL ANALYSIS, THE MOST PROBABLE ROOT CAUSE IS ATTRIBUTED TO THE CONTACT OF THE BALLOON WITH BONE SPLINTERS AND/OR SURGICAL TOOL DURING SURGERY.

    Additional Manufacturer Narrative · 1

    (B)(6). (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 A PATIENT UNDERWENT AN UNKNOWN BALLOON KYPHOPLASTY PROCEDURE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON RUPTURED AT A PRESSURE OF 200 PSI. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126343 KYPHON XPANDER II EU ARTHROSCOPE HRX MDT KYPHON NEUCHATEL MFG 0006635602

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR