BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCED CEMENT MIXING BOWL AND 180-GRAM CEMENT CARTRIDGE

    MDR report key: 3002354 · Received March 13, 2013

    Report

    Report Number
    0001811755-2013-00515
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    STRYKER INSTRUMENTS-PUERTO RICO
    Product Code
    JDZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS DISCARDED AT THE USER FACILITY.

    Description of Event or Problem · 1

    DURING PREPARATION FOR USE, IT WAS NOTICED THAT THERE WAS A SPECK OF DUST INSIDE THE ADVANCED CEMENT MIXING BOWL PACKAGE. THERE WAS NO PATIENT INVOLVEMENT, AND THERE WERE NO USER INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106081 ADVANCED CEMENT MIXING BOWL AND 180-GRAM CEMENT CARTRIDGE MIXER, CEMENT, FOR CLINICAL USE JDZ STRYKER INSTRUMENTS-PUERTO RICO 12230012

    Patients

    Seq Age Sex Outcome Treatment
    1