BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSCOPE

    MDR report key: 2832232 · Received November 14, 2012

    Report

    Report Number
    2953769-2012-00163
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    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

    (B)(4). HOSPITAL. 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 BALLOON KYPHOPLASTY WAS PERFORMED ON A PATIENT AT THE T6 LEVEL TO TREAT A VERTEBRAL COMPRESSION FRACTURE. THE SURGEON ATTEMPTED TO INSERT THE IBTS (INFLATABLE BALLOON TAMPS) INTO THE VERTEBRAL BODY, HOWEVER, BOTH IBT'S FAILED TO ADVANCE DOWN THE DISTAL TIP OF THE WORKING CANNULA. REPORTEDLY, AFTER SEVERAL ATTEMPTS, THE SURGEON RE-DRILLED AND RUBBED SALINE ON THE IBTS IN AN EFFORT TO LUBRICATE AND ASSIST IN INSERTION BUT NEITHER IBT WOULD ADVANCE THROUGH THE DISTAL TIP OF THE WORKING CANNULA. A NEW KIT WAS USED TO COMPLETE THE CASE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHROSCOPE HRX MDT KYPHON NEUCHATEL MFG NA 0006279872 (X2)

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR OSTEOINTRODUCER, BBD, DRILL, CANNULA, SYRINGE