BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2220373 · Received August 23, 2011

    Report

    Report Number
    1030489-2011-01085
    Event Type
    Injury
    Date Received
    August 23, 2011
    Report Date
    July 28, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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. A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLORATION OF FUSION WITH REMOVAL OF POSTERIOR SEGMENTAL INSTRUMENTATION AND L5-S1 LAMINECTOMY WITH REFUSION USING RHBMP-2/ACS. THE PATIENT WAS DISCHARGED TO A SKILLED NURSING FACILITY. THE PATIENT RETURNED TO THE HOSPITAL SEVEN DAYS AFTER DISCHARGE WITH A FEVER UP TO 103 ASSOCIATED WITH CHILLS AND RIGOR DURING THE PREVIOUS TWO DAYS. UPON RE-ADMISSION TO THE HOSPITAL, BLOOD WAS COLLECTED FOR CULTURE AND TESTED POSITIVE FOR (B)(6). FIVE DAYS LATER, A LUMBAR INCISION WAS MADE AND DRAINAGE FOR CULTURE WAS COLLECTED AND TESTED POSITIVE FOR (B)(6). INCREASED LOWER BACK PAIN AND A MILD HEADACHE WITH DRAINAGE FROM THE INCISION SITE WAS NOTED. THE PATIENT WAS DISCHARGED 6 DAYS AFTER THE PROCEDURE. PRIOR TO DISCHARGE, THE PATIENT WAS GIVEN A COURSE OF ANTIBIOTICS. NO ADDITIONAL COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA M111054AAF

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention