BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 5540404 · Received April 1, 2016

    Report

    Report Number
    1030489-2016-00876
    Event Type
    Injury
    Date Received
    April 1, 2016
    Report Date
    March 4, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: AUTHORS- SUNIL KUKREJA, OSAMA I AHMED, JUSTIN HAYDEL, ANIL NANDA, ANTHONY H SIN. TITLE "COMPLICATIONS OF ANTERIOR CERVICAL FUSION USING A LOW-DOSE RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2". AVERAGE AGE: 51.3 YRS. GENDER: 80 MALES AND 117 FEMALES. (B)(4) LOCATION : OTHER. EVENT LOCATION OTHER : UNKNOWN. 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 MEDTRONIC, INC.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A PUBLICATION TITLED "COMPLICATIONS OF ANTERIOR CERVICAL FUSION USING A LOW-DOSE RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2", A TOTAL OF 197 PATIENTS WITH THE MEAN AGE OF 51.3 YEARS AND MALE TO FEMALE RATIO OF 1.01 WERE INCLUDED IN THE STUDY. THE MEAN DURATION OF FOLLOW-UP WAS 27.5 MONTHS (RANGE 9-43 MONTHS). THE MAJORITY OF PATIENTS UNDERWENT SINGLE LEVEL ACFS (N=110, 55.8%), WHILE 2, 3, 4 LEVELS ACFS WERE PERFORMED IN 72 (N=36.5%), 13 (6.6%), 2 (1%) PATIENTS RESPECTIVELY. MATERIALS AND METHODS: IN THE MAJORITY OF CASES (N=191) POLYETHERETHERKETONE (PEEK) CAGES WERE USED AS A SPACER DEVICE AND THE CONSTRUCT WAS SUPPLEMENTED WITH ANTERIOR CERVICAL PLATE. IN PATIENTS, PEEK PREVAIL DEVICE WAS USED, WHICH HAS INBUILT SLOTS FOR SELF DRILLING SCREWS. CAGES WERE FILLED WITH RHBMP-2 BONE GRAFT SUBSTITUTE, WHICH HAS 2 COMPONENTS: A RECONSTITUTED SOLUTION CONTAINING RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2 (RHBMP-2) AND AN ABSORBABLE COLLAGEN SPONGE (ACS). ONE POINT FOUR (1.4) ML OF RHBMP-2 CONTAINING 2.1MG WAS SOAKED WITH ACS MEASURING 5.08×2.54×0.5 CM. WE PLACED ONLY 1/3 OF SPONGE WITHIN THE CAGE (MEASURING 1.7×2.54×0.5 CM), WHICH WOULD DELIVER 0.7MG OF RHBMP-2 PER LEVEL CONSIDERING A HOMOGENOUS DISTRIBUTION OF THIS PROTEIN WITHIN THE SPONGE (FIG. 1A). NO ADDITIONAL ACS WAS FILLED AROUND THE CAGE. IN A LARGE NUMBER OF THE PATIENTS (N=102), WE ALSO USED DEMINERALIZED BONE MATRIX (DBM), WHICH WAS PLACED FROM THE TOP AND THE BOTTOM OVER THE CENTRALLY LOCATED RHBMP-2 WITHIN THE PEEK CAGE. SIXTEEN (16) PATIENTS DEVELOPED SEVERE POSTOPERATIVE DYSPHAGIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198335 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 Other