BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPLEX SYSTEM W/ VERTAPLEX W/O NEEDLES

    MDR report key: 3823264 · Received May 21, 2014

    Report

    Report Number
    0001811755-2014-01844
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    STRYKER INSTRUMENTS-PUERTO RICO
    Product Code
    LOD
    PMA / PMN Number
    K072118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE USER FACILITY; IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF THE REPORTED MALFUNCTION WITHOUT AN EVALUATION OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A KYPHOPLASTY THE DELIVERY TUBE SNAPPED AT THE DISTAL TIP OF THE AUTOPLEX SYSTEM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY UTILIZING BACK-UP EQUIPMENT. NO CLINICALLY SIGNIFICANT DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303644 AUTOPLEX SYSTEM W/ VERTAPLEX W/O NEEDLES BONE CEMENT LOD STRYKER INSTRUMENTS-PUERTO RICO UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1