BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEBRON PSS PEDICLE SCREW SYSTEM

    MDR report key: 1036968 · Received April 30, 2008

    Report

    Report Number
    3004435519-2008-00001
    Event Type
    Malfunction
    Date Received
    April 30, 2008
    Date of Event
    May 2, 2006
    Report Date
    June 2, 2006
    Manufacturer
    VERTEBRON, INC.
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO COMPONENTS WERE RETURNED TO VERTEBRON FOR EVALUATION. UNABLE TO DETERMINE THE CAUSE OF THE EVENT. THE TWO PSS TORQUE LIMITERS WERE RETURNED AND FOUND TO BE WITHIN TOLERANCE. THE PROCESS OF SCREW FIXATION IS TECHNIQUE SENSITIVE AND CARE MUST BE TAKEN TO ENSURE THAT THE SCREWS ARE PROPERLY ANGLED AND FULLY TIGHTENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REVIEW OF 1-MONTH POST-OP X-RAYS IT WAS SEEN THAT A PSS ROD WAS NOT IN CONTACT WITH THE LOWEST 8.5 X 40MM PSS MA SCREW. THE SURGEON HAS NO PLANS TO PERFORM A REVISION SURGERY AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEBRON PSS PEDICLE SCREW SYSTEM SPINAL IMPLANT MNI VERTEBRON, INC. 922-8540 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR