BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STREAMLINE OCT OCCIPITO CERVICO THORACIC SYSTEM

    MDR report key: 5785433 · Received July 12, 2016

    Report

    Report Number
    1833824-2016-00023
    Event Type
    Injury
    Date Received
    July 12, 2016
    Report Date
    July 12, 2016
    Manufacturer
    PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL)
    Product Code
    KWP
    PMA / PMN Number
    K150254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO MORE INFORMATION THAT COULD BE GATHERED FROM THE INITIAL REPORTER. ACCORDING TO THIS INITIAL REPORTER, THERE HAS BEEN NO ACTION TAKEN TO THIS POINT. IT IS UNKNOWN THAT THE SYMPTOMS THAT THE PATIENT CLAIMS TO HAVE EXPERIENCED WERE CAUSED BY OUR DEVICES. PIONEER SURGICAL TECHNOLOGY SENT TO THE ALLERGY CLINIC THE CHEMICAL COMPOSITION INFORMATION OF THE DEVICES THAT WERE IMPLANTED INTO THE PATIENT. THE MATERIAL USED IN THIS SPINAL RODDING SYSTEM IS MEDICAL GRADE TITANIUM ALLOY AND COBALT CHROMIUM. BOTH OF THESE MATERIALS ARE LABELED IN THE INSTRUCTIONS FOR USE AS WELL AS ON THE INDIVIDUAL IMPLANT LABELS. ALSO IN THE "PATIENT SELECTION" SECTION OF THE INSTRUCTIONS FOR USE THAT IS SUPPLIED WITH ALL IMPLANTS, IT STATES THAT "IN SELECTING PATIENTS FOR INTERNAL FIXATION DEVICES, THE FOLLOWING FACTORS CAN BE OF EXTREME IMPORTANCE TO THE EVENTUAL SUCCESS OF THE PROCEDURE...FOREIGN BODY SENSITIVITY. MATERIAL SENSITIVITY TESTS SHOULD BE CONDUCTED PRIOR TO MATERIAL SELECTION OR IMPLANTATION." DEVICE REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PIONEER SURGICAL TECHNOLOGY BY AN ALLERGY CLINIC NURSE THAT ONE OF THEIR PATIENTS BELIEVE THAT THEY HAD AN ALLERGIC REACTION TO SOME OF PIONEER SURGICAL'S STREAMLINE OCT SYSTEM'S SPINAL IMPLANTS. THE PATIENT STARTED HAVING ADVERSE EFFECTS AFTER THIS SPINAL FUSION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440370 STREAMLINE OCT OCCIPITO CERVICO THORACIC SYSTEM POSTERIOR OCCIPITO-CERVICO-THORACIC SPINAL IMPLANTS KWP PIONEER SURGICAL TECHNOLOGY (D.B.A. RTI SURGICAL) UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other