BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTHROSCOPE

    MDR report key: 8459103 · Received March 28, 2019

    Report

    Report Number
    2953769-2019-00008
    Event Type
    Malfunction
    Date Received
    March 28, 2019
    Date of Event
    February 27, 2019
    Report Date
    May 2, 2019
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    HRX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PRODUCT ANALYSIS RESULT: VISUAL OPTICAL FUNCTIONAL VISUAL AND OPTICAL EXAMINATION OF THE IBT BALLOON IDENTIFIED A RADIAL SHARP CUT PERPENDICULAR TO THE IBT SHAFT AT THE DISTAL LOBE OF THE BALLOON. FUNCTIONAL CHECK WITH A SAMPLE SYRINGE CONFIRMED THE BALLOON WAS LEAKING AT THE TIP. THE LOCATION OF THE BALLOON RUPTURE IS CONSISTENT WITH IN VIVO CONTACT WITH SHARP OBJECT, SUCH AS BONE SPLINTERS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# KE152, 510K# K123771 AND UDI (B)(4) IS APPROVED FOR SALE IN US. 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. EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT BALLOON KYPHOPLASTY SURGERY DUE TO FRACTURE AT T8. INTRA-OP, THE BALLOON RUPTURED WHEN IT WAS BEING INFLATED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253232 ARTHROSCOPE ARTHROSCOPE HRX MDT KYPHON NEUCHATEL MFG NA 0009340117

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR