BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPLEX SYSTEM WITH VERTAPLEX HV W/O NEEDLES

    MDR report key: 2962156 · Received January 24, 2013

    Report

    Report Number
    2648666-2013-90017
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 28, 2012
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    FQH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVAL. THE REASON FOR THE SERIALIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CEMENT LEAKED WHEN MIXING WITH THE AUTOPLEX SYSTEM AND THE EXTENSION TUBE BROKE DURING PREPARATION PRIOR TO A PROCEDURE. A BACK-UP KIT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY, WITH NO PT OR USER INJURIES OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34675 AUTOPLEX SYSTEM WITH VERTAPLEX HV W/O NEEDLES FQH STRYKER INSTRUMENTS PUERTO RICO 12339012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK