BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3884590 · Received June 19, 2014

    Report

    Report Number
    1030489-2014-02814
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 21, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: VEERAVAGU ET AL. THE USE OF BONE MORPHOGENETIC PROTEIN IN THORACOLUMBAR SPINE PROCEDURES: ANALYSIS OF THE MARKETSCAN LONGITUDINAL DATABASE. THE SPINE JOURNAL (2014). DOI: 10.1016/J.SPINEE.2014.05.010. MEAN AGE 53.5 YRS. SEX: 10049 FEMALES, 7406 MALES. IMPLANT DATE: 2006-2010. (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. 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 A MATCHED COHORT OF 52,259 PATIENTS UNDERGOING THORACOLUMBAR FUSION SURGERY FROM 2006 TO 2010 IN THE UNITED STATES WAS IDENTIFIED IN THE MARKETSCAN DATABASE. PATIENTS WITHOUT BMP TREATMENT (N=34,840) WERE MATCHED 2-TO-1 TO PATIENTS RECEIVING BMP (N=17,455). ONE THOUSAND SIX HUNDRED PTS UNDERWENT ANTERIOR PROCEDURES, 11912 UNDERWENT POSTERIOR DECOMPRESSION, AND 16237 HAD POSTERIOR INSTRUMENTATION; 2762 PATIENTS HAD COMPLICATIONS WITHIN 30 DAYS OF SURGERY. RATES OF HEMATOMA, PULMONARY COMPLICATIONS, PE, NEUROLOGICAL COMPLICATIONS, NEW MALIGNANCY, 30-DAY READMISSION RATE, MORTALITY AT IN DEX PROCEDURE, MORTALITY AT 30 ¿DAY FOLLOW UP, RETROGRADE EJACULATION, INFERTILITY, AND ANTIDEPRESSANT PRESCRIPTION WERE NOT STATISTICALLY SIGNIFICANTLY DIFFERENT BETWEEN THE BMP TREATMENT AND THE CONTROL GROUPS. THERE WERE STATISTICALLY SIGNIFICANTLY HIGHER RATES OF INFECTION, WOUND DEHISCENCE, AND WOUND COMPLICATIONS IN THE CONTROL GROUP. THREE HUNDRED EIGHT PATIENTS DEVELOPED NEW DEEP VENOUS THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361442 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 00054 YR Required Intervention