BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSCOPE

    MDR report key: 3192966 · Received June 27, 2013

    Report

    Report Number
    2953769-2013-00100
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 30, 2013
    Report Date
    July 25, 2013
    Manufacturer
    MEDTRONIC SPINE LLC.
    Product Code
    HRX
    PMA / PMN Number
    K981251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). LOCATION : HOSPITAL.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PRODUCT ANALYSIS : VISUAL AND OPTICAL EXAMINATION OF THE IBT BALLOON IDENTIFIED A RADIAL SHARP CUT PERPENDICULAR TO THE IBT SHAFT AT THE PROXIMAL LOBE OF THE BALLOON. THE MORPHOLOGY, LOCATION AND TIMING OF THE BALLOON RUPTURE IS CONSISTENT WITH IN VIVO CONTACT WITH SHARP OBJECT, SUCH AS BONE SPLINTERS. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH IN VIVO CONTACT WITH SHARP OBJECT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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. DURING THE PROCEDURE, ONE OF THE BALLOONS "LEAKED" WHILE " EXPANDING WITH CONTRAST MEDIUM IN THE VERTEBRAL BODY TO THE 250P, 2.5ML'. ACCORDING TO THE REPORT, "THE C-ARM MACHINE SHOWED THERE WAS LITTLE CONTRAST MEDIUM IN THE VERTEBRAL BODY. AFTER CHANGING A NEW BALLOON, THE SURGERY WENT ON." NO FRAGMENTS OF THE BALLOON WERE LEFT IN THE PATIENT AND NO ALLERGIC REACTION TO THE CONTRAST MEDIA WAS REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293883 ARTHROSCOPE HRX MEDTRONIC SPINE LLC. NA 0005798469

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR