BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEAR MIX VACUUM MIXING SYSTEM

    MDR report key: 11444506 · Received March 9, 2021

    Report

    Report Number
    11444506
    Event Type
    Malfunction
    Date Received
    March 9, 2021
    Date of Event
    February 3, 2021
    Report Date
    February 10, 2021
    Manufacturer
    SUMMIT MEDICAL LTD.
    Product Code
    KIH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A CLEAR MIX VACUUM MIXING SYSTEM "EXPLODED" DURING THE CASE WHILE MIXING BONE CEMENT. SOME OF THE BONE CEMENT IS ON THE INSTRUMENTS AND TRIALS AND CANNOT BE REMOVED. NO HARM TO PATIENT. A NEW DISPOSABLE AND MORE BONE CEMENT WAS MIXED TO REPLACE THE FAILED MIXTURE. MANUFACTURER RESPONSE FOR CLEAR MIX VACUUM MIXING SYSTEM, (BRAND NOT PROVIDED) (PER SITE REPORTER). WE HAVE REQUESTED THEY REPLACE THE FAILED PRODUCT AND THE DAMAGED INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343329 CLEAR MIX VACUUM MIXING SYSTEM DISPENSER, CEMENT KIH SUMMIT MEDICAL LTD. 414702 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1