BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON EXPRESS INFLATABLE BONE TAMP

    MDR report key: 7339802 · Received March 14, 2018

    Report

    Report Number
    1030489-2018-00394
    Event Type
    Malfunction
    Date Received
    March 14, 2018
    Date of Event
    February 14, 2018
    Report Date
    June 29, 2018
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HRX
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR SALE IN THE US BUT A SIMILAR PART WITH CATALOGUE# KE102 AND 510K# K123771 AND (B)(4) IS APPROVED FOR SALE IN THE 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE BALLOON HAS A RUPTURE ON THE PROXIMAL PEAK. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE BALLOON COMING IN CONTACT WITH BONE SPLINTER WHILE THE BALLOON IS INFLATED IN THE VERTEBRAL BODY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    LEVELS IMPLANTED: T9 PRE-OPERATIVE DIAGNOSIS: PROSTATE CANCER - BONE METS (TUMOR WAS OSTEOBLASTIC AND OSTEOLYTIC). IT WAS REPORTED THAT INTRA-OP, THE BALLOON WAS RUPTURED DURING INFLATION AT A PSI OF 362. THE DEVICE CAME IN CONTACT WITH THE PATIENT. PATIENT WAS UNHARMED AND SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITH CEMENT INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182128 KYPHON EXPRESS INFLATABLE BONE TAMP ARTHROSCOPE HRX MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1