BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRYKER COMMUNICATIONS

    MDR report key: 585864 · Received March 15, 2005

    Report

    Report Number
    585864
    Event Type
    Injury
    Date Received
    March 15, 2005
    Date of Event
    March 4, 2005
    Report Date
    March 14, 2005
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    FSY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING THE COURSE OF THEIR OPERATIVE PROCEDURE, IT WAS NOTED THAT CONTAMINATION FROM THE RIGHT POLE HAD CONTAMINATED THE OPERATIVE FIELD, SPECIFICALLY THE IMPLANT THAT WAS CHOSEN TO BE PLACED IN THEIR NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER COMMUNICATIONS SPINDLE DUEL RIGHT TYPE 210720 FSY STRYKER COMMUNICATIONS 682-000-102 *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization