BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1212564 · Received October 24, 2008

    Report

    Report Number
    1030489-2008-00597
    Event Type
    Injury
    Date Received
    October 24, 2008
    Report Date
    September 25, 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 EVAL. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A TLIF WITH BILATERAL FACETECTOMY USING RHBMP-2/ACS. IMMEDIATELY POST-OP, THE PT DEVELOPED A LOW GRADE FEVER. WORK UP WAS NEGATIVE. WOUND, WBC AND CULTURES WERE ALL WITHIN NORMAL LIMITS. THERE WAS NO EVIDENCE OF INFECTION ON IMAGING. THE PT WAS PLACED ON ANTIBIOTICS, AND THE FEVER PERSISTED FOR TWO WEEKS BEFORE IT BROKE. SED RATE WAS 80, AND FELL TO 4 ONCE THE FEVER BROKE.

    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