BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CALIX LUMBAR SPINAL IMPLANT SYSTEM

    MDR report key: 5071425 · Received September 11, 2015

    Report

    Report Number
    3005031160-2015-00017
    Event Type
    Injury
    Date Received
    September 11, 2015
    Date of Event
    August 12, 2015
    Report Date
    August 12, 2015
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    MAX
    PMA / PMN Number
    K131350
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RECEIVED BY MANUFACTURER.

    Additional Manufacturer Narrative · 1

    WHILE CALIX AND FORTEX TRAYS WERE RETURNED AND AVAILABLE FOR INVESTIGATION ON (B)(6) 2015, THE EXPLANTED CALIX IMPLANTS WERE NOT RETURNED WITHIN THE TRAYS. EACH TRAY WAS INSPECTED AS PART OF THE COMPLAINT INVESTIGATION. DEVICE NOT RECEIVED BY MANUFACTURER.

    Description of Event or Problem · 1

    REPORTED VIA PHONE AND E-MAIL; THE (B)(6) HOSPITAL IN (B)(6) AND DR. (B)(6), WHO OPERATES THERE, REPORTED VIA THE DISTRIBUTOR, (B)(4), THAT THE HOSPITAL IS EXPERIENCING 'AN INFECTION PROBLEM' AND 'HAVING ISSUES WITH THEIR STERILIZATION AND VALIDATION PROCESS'. OF TEN PATIENTS REPORTED TO HAVE SHOWN LARGE WOUND INFECTIONS, POSSIBLY CAUSED BY A PSEUDOMONA BACTERIA, THIS REPORT IS FOR ONE OF THOSE PATIENTS. THIS PATIENT IS REPORTED TO HAVE HAD A LARGE INFECTION AT THE SURGICAL WOUND SITE, WITH ONE REVISION SURGERY TO REMOVE THE CALIX IMPLANT AND INFECTIOUS MATTER FROM AROUND THE IMPLANT SITE. THIS PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS BEFORE AND AFTER THE REVISION AT AN UNSPECIFIED DOSAGE. IT IS ESTIMATED THAT THE LENGTH OF STAY AT THE HOSPITAL HAS BEEN APPROXIMATELY ONE TO TWO WEEKS, BUT THE EXACT DATES WERE NOT GIVEN. THIS PATIENT WAS ALSO REPORTED TO BE OVER EIGHTY YEARS OLD, WEAK DUE TO THE REVISION SURGERY AND BLOOD LOSS, AND MAY HAVE PNEUMONIA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT BY (B)(6) 2015, THE LAST PATIENT HAD LEFT THE HOSPITAL. NO NEW CASES OF INFECTION ASSOCIATED WITH THE CALIX TLIF SYSTEM HAVE BEEN REPORTED FROM THE HOSPITAL IN LEER VIA SURGICO. THE COMPLETE CONSIGNMENT WAREHOUSE OF CALIX SURGICAL TRAYS, AND ADDITIONAL FORTEX SURGICAL TRAYS, WERE RECEIVED BY THE MANUFACTURER, X-SPINE SYSTEMS, THE DEVICES WERE NOT AVAILABLE FOR INVESTIGATION UNTIL 10/30/2015. NO EXPLANTED CALIX IMPLANTS WERE RETURNED FOR EVALUATION BY THE COMPLAINANT OR RECEIVED BY THE MANUFACTURER X-SPINE. WITHIN THE RETURNED G23 FORTEX SURGICAL TRAY 6 PEDICAL SCREWS WERE FOUND TO HAVE POSSIBLE SIGNS OF USE UPON EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601939 CALIX LUMBAR SPINAL IMPLANT SYSTEM LUMBAR SPINAL FUSION IMPLANT SYSTEM MAX X-SPINE SYSTEMS, INC. X034-0002

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R