BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSCOPE

    MDR report key: 3120652 · Received May 20, 2013

    Report

    Report Number
    2953769-2013-00077
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 23, 2013
    Report Date
    August 1, 2013
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    HRX
    PMA / PMN Number
    K981251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PRODUCT ANALYSIS : PRESENCE OF BLOOD INDICATES THE INSTRUMENT HAS BEEN USED DURING SURGERY. FUNCTIONAL ANALYSIS WAS NOT POSSIBLE, DUE TO A HOLE ON THE BALLOON OF THE IBT. VISUAL ANALYSIS SHOWS A LONGITUDINAL RUPTURE ON THE BALLOON FROM THE DISTAL PEAK TO THE PROXIMAL PEAK OF THE BALLOON. THE MORPHOLOGY, LOCATION ON THE INSTRUMENT AND TIMING OF THE BALLOON RUPTURE IS CONSISTENT WITH IN VIVO CONTACT WITH SHARP OBJECT, SUCH AS BONE SPLINTERS.

    Additional Manufacturer Narrative · 1

    (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 A BALLOON KYPHOPLASTY PROCEDURE (BKP) AT TH12 TO TREAT A COMPRESSION FRACTURE. IT WAS REPORTED THAT THE BALLOON RUPTURED ON THE LEFT SIDE DURING INFLATION AND CONTRAST MEDIA LEAKED. NO BALLOON FRAGMENTS REMAINED IN THE PATIENT AND THERE WERE NO ALLERGIC SYMPTOMS. PER THE REPORT, THE BALLOON WAS INFLATED TO "150 PSI AND THE VOLUME WAS 3.5ML WHEN THE BALLOON RUPTURED." AFTER THE EVENT, THE CONTRAST MEDIA WAS SUCTIONED OUT AND THE SURGEON USED A NEW INFLATABLE BONE TAMP (IBT) TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222205 ARTHROSCOPE HRX MDT KYPHON NEUCHATEL MFG NA 0006646604

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR