BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSCOPE

    MDR report key: 3033134 · Received April 3, 2013

    Report

    Report Number
    2953769-2013-00055
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 5, 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

    (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) TO TREAT A COMPRESSION FRACTURE AT T12. IT WAS REPORTED THAT THE BALLOON RUPTURED DURING THE PROCEDURE AND CONTRAST MEDIA LEAKED IN THE VERTEBRAE HOWEVER, THERE WERE NO CHANGES IN THE PATIENT'S VITAL SIGNS AND NO ALLERGY SYMPTOMS TO THE CONTRAST. NO BALLOON FRAGMENTS WERE LEFT IN THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER BALLOON. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137138 ARTHROSCOPE HRX MDT KYPHON NEUCHATEL MFG NA 0006452579

    Patients

    Seq Age Sex Outcome Treatment
    1 BKP