BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER INTERVENTIONAL SPINE

    MDR report key: 6956280 · Received October 17, 2017

    Report

    Report Number
    6956280
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    September 28, 2017
    Report Date
    September 28, 2017
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    HRX
    UDI-DI
    0705115000
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PERCUTANEOUS VERTEBROPLASTY. IVAS BALLOON CATHETER RUPTURED DURING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734120 STRYKER INTERVENTIONAL SPINE IVAS INFLATABLE VERTEBRAL AUGMENTATION SYSTEM HRX STRYKER INSTRUMENTS 15219012 0705115000

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR