BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEWPORT 2 INSTRUMENT

    MDR report key: 3772253 · Received March 31, 2014

    Report

    Report Number
    2032593-2014-00015
    Event Type
    Other
    Date Received
    March 31, 2014
    Report Date
    March 17, 2014
    Manufacturer
    SEASPINE, INC.
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE REPORTED INCIDENT HAVE BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    A RETURNED NEWPORT INSTRUMENT SET (B)(4) CONTAINED MARKETING INSTRUMENTS (DEMOS) IN ADDITION TO INSTRUMENTS MEANT FOR HUMAN USE. ON (B)(6) 2014 ADDITIONAL INFO WAS RECEIVED. THE (B)(4) INSTRUMENT SET WAS SHIPPED TO A US DISTRIBUTOR (B)(4) ON (B)(6) 2013. ON (B)(6) 2013 THE DISTRIBUTOR SHIPPED THAT SET TO A SECOND DISTRIBUTOR (B)(4). ON (B)(6) 2013 THE (B)(4) DISTRIBUTOR REP DEMONSTRATED THE USE OF A NEW PORT SYSTEM MARKETING (DEMO) SET TO A SURGEON ALONG WITH A CORAL SYSTEM DEMO SET FOR A SURGERY THAT WAS SCHEDULE 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 INSTRUMENTS MEANT FOR HUMAN USE AND THE NEW PORT INSTRUMENT 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 INSTRUMENT SET AND THE SET CONTAINING INSTRUMENTS MEANT FOR HUMAN USE WERE BOTH PRESENT IN THE OPERATING ROOM. ON (B)(6) 2014 THE (B)(4) SET (CONTAINING INSTRUMENTS 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)(6) 2014, THE (B)(4) SET WAS RETURNED TO INTEGRA. IT WAS DISCOVERED, AT THAT TIME THAT MARKETING DEMO INSTRUMENTS WERE INSIDE THE (B)(4) SET. BASED ON CURRENT AVAILABLE INFO, THE SET THAT CONTAINED MARKETING DEMOS MAY HAVE BEEN USED IN TWO DIFFERENT SURGERIES PERFORMED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190105 NEWPORT 2 INSTRUMENT SPINAL INSTRUMENTS-FIXED NKB SEASPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1