BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3822109 · Received May 20, 2014

    Report

    Report Number
    1030489-2014-02588
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 29, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: JAIN ET AL. RHBMP USE IN CERVICAL SPINE SURGERY: ASSOCIATED FACTORS AND IN-HOSPITAL COMPLICATIONS. J BONE JOINT SURG AM. 2014;96:617-23. (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 IN A LITERATURE PUBLICATION THAT THE NATIONWIDE INPATIENT SAMPLE (NIS) DATABASE RECORDS FROM 2003 THROUGH 2010 WERE SEARCHED. DURING THE STUDY PERIOD, 1,064,372 CERVICAL FUSION PROCEDURES WERE PERFORMED, INCLUDING 924,004 ANTERIOR, 111,194 POSTERIOR, AND 29 ,174 CIRCUMFERENTIAL PROCEDURES. OVERALL, RHBMP WAS USED IN 84,726 (7.96%) OF THE CERVICAL FUSION PROCEDURES (RHBMP GROUP), INCLUDING 63,556 ANTERIOR, 16,723 POSTERIOR, AND 4447 CIRCUMFERENTIAL PROCEDURES. THE REMAINING PATIENTS HAD SURGERY WITHOUT USE OF RHBMP. 593 PATIENTS DEVELOPED HEMATOMA/SEROMA FORMATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300488 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 Other