BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEBRON PSS PEDICLE SCREW SYSTEM

    MDR report key: 3008482 · Received September 4, 2008

    Report

    Report Number
    3004435519-2008-00003
    Event Type
    Malfunction
    Date Received
    September 4, 2008
    Date of Event
    July 28, 2008
    Report Date
    August 27, 2008
    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

    VERTEBRON IS STILL IN THE PROCESS OF FINALIZING ITS REVIEW OF THIS COMPLAINT AND PRODUCT. A FOLLOW-UP REPORT WILL FORWARD TO FDA SHORTLY ONCE THE INVESTIGATION OF THE COMPONENTS INVOLVED CAN BE COMPLETED. 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 SURGERY A PSS MS SCREW HAD SPLAYED AND THE LOCKING CAP COULD NOT BE SECURED ONTO THE SCREW/ROD CONSTRUCT. THIS OCCURRED DURING SCREW MANIPULATION WITH THE CAP INSERTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEBRON PSS PEDICLE SCREW SYSTEM SPINAL IMPLANT MNI VERTEBRON, INC. 922-5550 AC0704A

    Patients

    Seq Age Sex Outcome Treatment
    1