BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSCOPE

    MDR report key: 3033675 · Received April 3, 2013

    Report

    Report Number
    2953769-2013-00056
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    HRX
    PMA / PMN Number
    K981251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT ANALYSIS: VISUALLY CONFIRMED BALLOON TEAR UPON EXAMINATION OF THE RETURNED INSTRUMENT. NO MATERIAL OR FUNCTIONAL DEFECTS ON CATHETER WERE IDENTIFIED. APPROXIMATELY ~270 DEGREE RADIAL RUPTURE AT BALLOON PEAK. INFLATION APPEARS TO HAVE BEEN PREFERENTIAL. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH CONTACT WITH BONE SPLINTERS DURING USAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BALLOON KYPHOPLASTY PROCEDURE AND DURING THE PROCEDURE, THE INFLATABLE BONE TAMP (IBT) RUPTURED AT 200 PSI. ACCORDING TO THE REPORT, THE PATIENT HAD NO KNOWN ALLERGY TO THE CONTRAST AND NO FRAGMENTS WERE LEFT BEHIND. NO OTHER COMPLICATIONS WERE REPORTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NEW BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137112 ARTHROSCOPE HRX MDT KYPHON NEUCHATEL MFG NA 0006193461

    Patients

    Seq Age Sex Outcome Treatment
    1 BKP KIT, CEMENT