BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4139440 · Received October 3, 2014

    Report

    Report Number
    1030489-2014-03795
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 4, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: COLE ET AL. USAGE OF RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN IN CERVICAL SPINE PROCEDURES: ANALYSIS OF THE MA RKETSCAN LONGITUDINAL DATABASE. J BONE JOINT SURG AM. 2014;96:1409-16. AVERAGE AGE: 50.8 YRS; GENDER: 1415 MALES, 1764 FEMALES; IMPLANT DATE: BETWEEN 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A RETROSPECTIVE ADMINISTRATIVE DATABASE STUDY WAS PERFORMED OF OVER 90,000 PATIENTS WHO UNDERWENT CERVICAL SPINE PROCEDURES IN THE UNITED STATES FROM 2006 TO 2010. THE AUTHORS USED THE MARKETSCAN RESEARCH DATABASE. 91,543 OF THE PATIENTS IN THE MARKETSCAN DATABASE UNDERWENT ACDF (WITH OR WITHOUT CONCOMITANT CERVICAL CORPECTOMY, AND WITH OR WITHOUT CONCOMITANT POSTERIOR CERVICAL SPINE PROCEDURES); 3179 OF THESE PATIENTS RECEIVED RHBMP INTRAOPERATIVELY. 141 PATIENTS IN THE RHBMP COHORT DEVELOPED NEW DYSPHAGIA WITHIN 30 DAYS OF THE INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620243 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 00051 YR Other