BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION CMS W/BRK FEM NZL

    MDR report key: 3123821 · Received May 22, 2013

    Report

    Report Number
    0001811755-2013-01163
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 24, 2013
    Report Date
    January 10, 2025
    Manufacturer
    STRYKER INSTRUMENTS-PUERTO RICO
    Product Code
    JDZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REVOLUTION CEMENT MIXING SYSTEM WAS BEING USED IN A PROCEDURE WHEN A BLACK SUBSTANCE WAS OBSERVED IN THE TUBING WHEN NEGATIVE PRESSURE WAS TAKEN TO THE MIXING KIT. THE ACCOUNT FELT THAT THERE WAS NO PROBLEM INSIDE THE CEMENT GUN AND USED IT TO COMPLETE THE PROCEDURE WITH NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225905 REVOLUTION CMS W/BRK FEM NZL MIXER, CEMENT, FOR CLINICAL USE JDZ STRYKER INSTRUMENTS-PUERTO RICO 13050012

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown