BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2880036 · Received December 19, 2012

    Report

    Report Number
    1030489-2012-02889
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 24, 2012
    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

    LITERATURE ARTICLE CITATION: LU ET AL. MULTILEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION WITH AND WITHOUT RHBMP-2: A COMPARISON OF DYSPHAGIA RATES AND OUTCOMES IN 150 PATIENTS. J NEUROSURG: SPINE. NOVEMBER 16, 2012; (DOI: 10.3171/2012.10.SPINE10231). PT AGE: MEAN AGE 51 YRS. PT SEX: 55 FEMALES, 45 MALES. DATES OF IMPLANT: 2002-2006. (B)(6). (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 A RETROSPECTIVE REVIEW WAS CONDUCTED OF 100 CASES INVOLVING PATIENTS TREATED WITH MULTILEVEL (2 OR MORE LEVELS) ACDF AUGMENTED WITH RHBMP-2 WITHIN A PEEK CAGE WITH PLATE PLACEMENT AND COMPARED THIS COHORT TO 50 CASES INVOLVING PROFILE-MATCHED PATIENTS TREATED WITH STANDARD ACDF WITH STRUCTURAL ALLOGRAFT (WITHOUT BMP) AND PLATING. ALL PATIENTS UNDERWENT ANTERIOR CERVICAL FUSIONS VIA THE SMITH-ROBINSON APPROACH AND RECEIVED 10 MG OF DEXAMETHASONE PRIOR TO INCISION. FOR THE BMP GROUP, WE USED A PEEK CAGE FILLED WITH A PORTION OF AN RHBMP-2-SOAKED COLLAGEN SPONGE AND SUPPLEMENTED WITH AN ANTERIOR CERVICAL PLATE. THE INCIDENCE OF DYSPHAGIA WAS RETROSPECTIVELY ASSESSED WITH THE SWAL-QOL SCALE. FUSION WAS ASSESSED BY FLEXION-EXTENSION LATERAL RADIOGRAPHS AT CLINIC FOLLOW-UP. OVERALL, THERE WAS AN INCREASED RATE OF SHORT-TERM COMPLICATIONS WITH THE USE OF RHBMP-2, WITH COMPLICATIONS NOTED IN 13 (13%) OF THE 100 PATIENTS IN THE BMP GROUP AND 4 (8%) OF THE 50 PATIENTS IN THE CONTROL GROUP. THERE WERE NO CASES OF PSEUDOARTHROSIS IN THE BMP GROUP. THREE PATIENTS HAD TRANSIENT RECURRENT LARYNGEAL NERVE PALSIES THAT ULTIMATELY RESOLVED.

    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 00051 YR Required Intervention