BEUDAMED
    FDA Adverse Event Other Summary report: N

    VERTEBRON PSS PEDICLE SCREW SYSTEM

    MDR report key: 1059623 · Received June 10, 2008

    Report

    Report Number
    3004435519-2008-00002
    Event Type
    Other
    Date Received
    June 10, 2008
    Date of Event
    May 6, 2008
    Report Date
    May 6, 2008
    Manufacturer
    VERTEBRON, INC.
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO COMPONENTS WERE RETURNED TO VERTEBRON FOR EVALUATION. UNABLE TO DETERMINE THE CAUSE OF THE EVENT. AFTER REVIEW OF THE PROVIDED X-RAYS, THERE WAS NO CLEAR INDICATION OF WHY THE LOCKING CAP BECAME DISLODGED. THE CONSTRUCT WAS ASSEMBLED USING A COMPETITORS RODS FOR WHICH TESTING HAS NOT BEEN PERFORMED. THIS COULD CONTRIBUTE TO REDUCE FRICTION SURFACE AREA CONTACT AND CLAMPING PRESSURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A T-20 LOCKING CAP LOOSENED. THE SURGEON USED THE VERTEBRON PSS PEDICLE SCREW SYSTEM WITH A DIFFERENT MANUFACTURERS RODS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK