BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEWPORT IMPLANT

    MDR report key: 3772303 · Received March 28, 2014

    Report

    Report Number
    2032593-2014-00014
    Event Type
    Other
    Date Received
    March 28, 2014
    Report Date
    March 17, 2014
    Manufacturer
    SEASPINE, INC.
    Product Code
    NKB
    PMA / PMN Number
    K083089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORT INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    A RETURNED NEWPORT IMPLANT SET ((B)(4)) CONTAINED MARKETING IMPLANTS (DEMOS) IN ADDITION TO IMPLANTS MEANT FOR HUMAN USE. ON (B)(4) 2014 ADDITIONAL INFORMATION WAS RECEIVED. THE (B)(4)IMPLANT SET WAS SHIPPED TO A US DISTRIBUTOR ((B)(4)) ON (B)(4) 2013. ON (B)(4) 2013 THE DISTRIBUTOR SHIPPED THAT SET TO A SECOND DISTRIBUTOR ((B)(4)). ON (B)(6) 2013 THE (B)(4) DISTRIBUTOR REPRESENTATIVE DEMONSTRATED THE USE OF A NEWPORT SYSTEM MARKETING (DEMO) SET TO A SURGEON ALONG WITH A CORAL SYSTEM - DEMO SET FOR A SURGERY THAT WAS SCHEDULED TO BE PERFORMED THE NEXT DAY ON (B)(6) 2013. THE SURGEON CHOSE TO USE THE NEWPORT SET FOR THE SURGERY. BOTH THE NEWPORT SET THAT CONTAINED IMPLANTS MEANT FOR HUMAN USE AND THE NEWPORT DEMO SET WENT THROUGH STERILE PROCESSING STERILIZATION AT THE SURGICAL FACILITY PRIOR TO THE SURGERY. ON (B)(6) 2013 (THE DAY OF THE SURGERY, THE MARKETING SET AND THE SET CONTAINING IMPLANTS MEANT FOR HUMAN USE WERE BOTH PRESENT IN THE OPERATING ROOM. ON (B)(6) 2014 THE (B)(4) SET (CONTAINING IMPLANTS MEANT FOR HUMAN USE AND MARKETING DEMOS) WAS SHIPPED BY (B)(4) TO ANOTHER DISTRIBUTOR ((B)(4)). ON (B)(6) 2014 THAT SET WAS BROUGHT INTO THE OPERATING ROOM AND USED FOR SURGERY. ON (B)(4) 2014, THE NWP-016 SET WAS RETURNED TO INTEGRA. IT WAS DISCOVERED, AT THAT TIME THAT MARKETING DEMO IMPLANTS WERE INSIDE THE (B)(4) SET. BASED ON CURRENT AVAILABLE INFORMATION, THE SET THAT CONTAINED MARKETING DEMOS MAY HAVE BEEN USED IN TWO DIFFERENT SURGERIES PERFORMED ON (B)(6) 2013 AND (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186595 NEWPORT IMPLANT SPINAL INSTRUMENTS-FIXED NKB SEASPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1