BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAULT STAND ALONE ALIF SYSTEM

    MDR report key: 2782818 · Received October 3, 2012

    Report

    Report Number
    3005739886-2012-00010
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 7, 2012
    Report Date
    September 7, 2012
    Product Code
    MAX
    PMA / PMN Number
    K103369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL WAS NOT POSSIBLE AS NO PRODUCT WAS RETURNED. AS A RESULT OF THIS REPORT THE SPINAL USA ENGINEERING DIRECTOR OBSERVED A VAULT ALIF PROCEDURE PERFORMED BY THIS SURGEON. IT WAS IDENTIFIED THAT THE SURGEON WAS NOT UTILIZING THE RECOMMENDED SPINAL USA INSTRUMENTATION, WHICH LIKELY CONTRIBUTED TO THE VAULT LOCK SCREW STRIPPING REPORTED. AS THE FIVE (5) EVENTS REPORTED WERE NOT RELATED TO MALFUNCTION DUE TO NON-CONFORMING PRODUCT, THEY ARE BEING REPORTED AS ONE EVENT, ATTRIBUTED TO USER ERROR. DISCUSSION BETWEEN THE SURGEON AND THE SPINAL USA ENGINEER DETERMINED THAT A CUSTOM INSTRUMENT WOULD BE DEVELOPED FOR THIS SURGEON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN FIVE (5) SEPARATE VAULT ALIF PROCEDURES PERFORMED BY ONE (1) SURGEON, THE VAULT LOCK SCREW STRIPPED BEFORE REACHING THE RECOMMENDED TORQUE VALUE ON THE TORQUE WRENCH. NO SIGNIFICANT DELAY TO PROCEDURE OR PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAULT STAND ALONE ALIF SYSTEM VAULT STAND ALONE ALIF SYSTEM MAX

    Patients

    Seq Age Sex Outcome Treatment
    1