BEUDAMED
    FDA Adverse Event Death Summary report: N

    VBT1315-AVAMAX BALLOON¿13G 15MM

    MDR report key: 7951484 · Received October 10, 2018

    Report

    Report Number
    0001811755-2018-01733
    Event Type
    Death
    Date Received
    October 10, 2018
    Date of Event
    September 5, 2018
    Report Date
    October 10, 2018
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    NDN
    UDI-DI
    07613327374469
    PMA / PMN Number
    K162062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DISCARDED

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT THE KYPHOPLASTY PROCEDURE WAS COMPLETED SUCCESSFULLY BUT THAT TWO DAYS LATER, THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791984 VBT1315-AVAMAX BALLOON¿13G 15MM VERTEBROPLASTY BONE CEMENT NDN STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN 07613327374469

    Patients

    Seq Age Sex Outcome Treatment
    1 Death (B)(4)