BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOPLEX SYSTEM WITH VERTAPLEX HV W/O NEEDLES

    MDR report key: 3863927 · Received June 10, 2014

    Report

    Report Number
    0001811755-2014-02109
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 14, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    NDN
    PMA / PMN Number
    K091606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REPORTED CONDITION CAN BE CONSIDERED CONFIRMED BASED ON EVALUATION OF THE RETURNED PRODUCT. THE INJECTOR HANDLE PRESENTED SOME RESISTANCE AND NOISE WHEN ROTATED. THE DEVICE WAS DISCARDED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE HANDLE OF THE AUTOPLEX WAS FOUND TO BE VERY STIFF AND THAT THE DEVICE WAS MAKING A LOUD NOISE WHILE TURNING, WHICH CAUSED A 30 MINUTE DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY UTILIZING BACK-UP EQUIPMENT. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE HANDLE OF THE AUTOPLEX WAS FOUND TO BE VERY STIFF AND THAT THE DEVICE WAS MAKING A LOUD NOISE WHILE TURNING, WHICH CAUSED A 30 MINUTE DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY UTILIZING BACK-UP EQUIPMENT. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341415 AUTOPLEX SYSTEM WITH VERTAPLEX HV W/O NEEDLES CEMENT, BONE, VERTEBROPLASTY NDN STRYKER INSTRUMENTS-KALAMAZOO 13072012

    Patients

    Seq Age Sex Outcome Treatment
    1