BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2192043 · Received August 4, 2011

    Report

    Report Number
    1030489-2011-01003
    Event Type
    Injury
    Date Received
    August 4, 2011
    Report Date
    July 6, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATALOG NUMBER OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE CATALOG # 7510600 AND # 7510200. IMPLANT DATES: (B)(6) 2011. (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 WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION. 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 A DLIF PROCEDURE FROM L2-L5 USING RHBMP-2/ACS, DLIF CAGES AND POSTERIOR ROD-SCREW CONSTRUCT. THE PATIENT THEN UNDERWENT THE 2ND AND 3RD STATED OF THE PROCEDURE (TLIF FROM T12 TO S1, USING ADDITIONAL RHBMP-2/ACS) ON THE 6TH AND 9TH DAYS POST-OP. THE PATIENT UNDERWENT A REVISION SURGERY 19 DAYS AFTER THE INITIAL SURGERY DUE TO HARDWARE FAILURE. DURING THE REVISION, A LARGE AMOUNT OF PARASPINAL FLUID WAS NOTED. CULTURES OF THE FLUID WERE POSITIVE FOR (B)(6). ADDITIONAL RHBMP-2/ACS WAS PLACED IN THE SITE DURING THIS PROCEDURE. OVER THE NEXT MONTH, THE PATIENT REQUIRED TWO SUBSEQUENT IRRIGATION AND DEBRIDEMENT PROCEDURES, DESPITE BEING ON ANTIBIOTICS. ALL SUBSEQUENT CULTURES WERE NEGATIVE. THE PATIENT REQUIRED PERCUTANEOUS DRAIN PLACEMENT FOR ONGOING DISCOMFORT FROM EPIDURAL FLUID COLLECTION. CULTURES AGAIN WERE NEGATIVE. CURRENTLY, THE PATIENT HAS HAD THE DRAIN REMOVED, AND HAS BEEN DISCHARGED, DESPITE A FLUID COLLECTION NOTED ON MRI. PATIENT'S LENGTH OF HOSPITAL STAY INCREASED BY 4-5 WEEKS DUE TO SPINAL FLUID COLLECTION.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R CAPSTONE