BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSTINCT JAVA SYSTEM BLOCKER

    MDR report key: 3925648 · Received June 17, 2014

    Report

    Report Number
    3003853072-2014-00007
    Event Type
    Injury
    Date Received
    June 17, 2014
    Report Date
    May 19, 2014
    Manufacturer
    ZIMMER SPINE
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    CASE AS 3003853072-2014-00005 AND 00006. IT WAS REPORTED THE BLOCKERS WERE FOUND TO BE LOOSE POST-OPERATIVELY. THE ORIGINAL SURGERY WAS PERFORMED TO TREAT KYPHOSIS AT T3-L3 WITH PONTE OSTEOTOMIES AT T4-T10. APPROXIMATELY SIX MONTHS POST-OPERATIVELY AT FOLLOW-UP IT WAS NOTED THAT THREE BLOCKERS WERE LOOSE (2 AT L3 AND 1 AT L2). REVISION SURGERY IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355941 INSTINCT JAVA SYSTEM BLOCKER INSTINCT JAVA SYSTEM BLOCKER NKB ZIMMER SPINE 046W0AN00002 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention