BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSS CROSS CONNECTOR

    MDR report key: 765402 · Received October 24, 2005

    Report

    Report Number
    3004435519-2005-00001
    Event Type
    Malfunction
    Date Received
    October 24, 2005
    Date of Event
    September 19, 2005
    Report Date
    October 20, 2005
    Manufacturer
    VERTEBRON, INC.
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT DESCRIBED IN THIS REPORT HAS TO DATE BE UNREPRODUCIBLE IN THE LAB. THE RING MAY HAVE BEEN PULLED FROM THE ASSEMBLY. THE CAM RING IS NOT DESIGNED AS A FORCE HOLDING COMPONENT. THE CAM RING IS INTENDED TO MAINTAIN THE CAM IN AN OPEN POSITION DURING SHIPPING. ALL BENCH TESTING; WITH RING PARTIALLY SEATED & WITH NO RING; DEMONSTRATED NO SIGNIFICANT EFFECT ON HOLDING FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAM RETAINING RING CAME OFF DURING TIGHTENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSS CROSS CONNECTOR SPINAL IMPLANT KWP VERTEBRON, INC. 916-3544 AC0205A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN