BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1212567 · Received October 24, 2008

    Report

    Report Number
    1030489-2008-00596
    Event Type
    Injury
    Date Received
    October 24, 2008
    Report Date
    September 24, 2008
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TLIF WITH BILATERAL FACETECTOMY USING RHBMP-2/ACS. IMMEDIATELY POST-OP, THE PATIENT DEVELOPED A LOW GRADE FEVER (TMAX 103). WORK UP WAS NEGATIVE. WOUND, WBC AND CULTURES WERE ALL WITHIN NORMAL LIMITS. SED RATE IS ELEVATED 86. THERE WAS NO EVIDENCE OF INFECTION ON IMAGING, ALTHOUGH A SMALL FLUID COLLECTION WAS VISIBLE. THE SURGEON DOES NOT BELIEVE THE FLUID COLLECTION IS THE SOURCE OF THE FEVER, AND IS NOT CONCERNED ABOUT IT. THE PATIENT HAS BEEN PLACED ON ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT INFUSE BONE GRAFT NEK MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization