BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIFUSE

    MDR report key: 5470675 · Received March 1, 2016

    Report

    Report Number
    1416980-2016-04321
    Event Type
    Injury
    Date Received
    March 1, 2016
    Report Date
    March 10, 2016
    Manufacturer
    BAXTER APATECH LTD
    Product Code
    LYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VOLUNTARY REPORT NUMBER: (B)(4). COMPLAINT NO: (B)(4). EVALUATION CODES WERE PROVIDED. THE DEVICE WAS NOT RETURNED FOR EVALUATION; HOWEVER, THE LOT NUMBER OF THE DEVICE WAS IDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A MASSIVE INFLAMMATORY REACTION COINCIDENT WITH 5ML ACTIFUSE USAGE DURING A SPINAL SURGICAL PROCEDURE. THE REACTION WAS MANIFESTED BY LEUKOCYTOSIS, FEVER AND INCREASE IN C-REACTIVE PROTEIN. THE REACTION OCCURRED ON THE FIRST POST-OPERATIVE DAY AFTER USE OF THE PRODUCT. THE CAUSE OF THE EVENT WAS NOT REPORTED. ON UNREPORTED DATE(S), THE PATIENT WAS TREATED WITH UNSPECIFIED BROAD SPECTRUM ANTIBIOTICS (ROUTE, MEDICATION, DOSAGE, FREQUENCY, AND DURATION NOT REPORTED) FOR THE INFLAMMATORY REACTION WITHOUT DEPRESSION OF SYMPTOMS. THE PATIENT HAD NO PRE-EXISTING RISK FACTORS FOR INFLAMMATION. AT THE TIME OF THIS REPORT, THE PATIENT WAS DISCHARGED TO HOME. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE PATIENT铠OUTCOME FROM THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127757 ACTIFUSE BONE GRAFTING MATERIAL, SYNTHETIC LYC BAXTER APATECH LTD ELS80K086GP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R