BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VBS W/BALLOON MED

    MDR report key: 5872031 · Received August 12, 2016

    Report

    Report Number
    3000270450-2016-10205
    Event Type
    Injury
    Date Received
    August 12, 2016
    Date of Event
    June 30, 2016
    Report Date
    July 26, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    NDN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NO PATIENT INFORMATION HAS BEEN PROVIDED. ADDITIONAL CODE- FZH, HXG, HTW, MJG. (B)(4). (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO ANOMALIES WERE DETECTED DURING DEVICE HISTORY RECORD REVIEW. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY THE SURGEON USED A VERTEBRA BALLOON SYSTEM (VBS) WITH THE FIRST TWO TEST BALLOONS. THE FIRST PHASE WENT WELL WITH THE INFLATION OF THE TWO (2) BALLOONS. IT IS IN THE SECOND PHASE THAT ONE OF THE TWO BALLOONS WITH THE STENT EXPLODED BEFORE THE MAXIMUM CONTENT WAS ALLOWED AND THE STENT THEREFORE HAD NOT FULLY EXTENDED. THE SURGEON REMOVED THE BALLOON BUT THE TIP OF THE STENT REMAINS ANCHORED IN THE VERTEBRA OF THE PATIENT WITHOUT BEING ABLE TO REMOVE IT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524428 VBS W/BALLOON MED VBS NDN SYNTHES SELZACH 1114053

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention