BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDUCTOS

    MDR report key: 3870944 · Received June 12, 2014

    Report

    Report Number
    1030489-2014-02747
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NEK
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: CICCIÙ ET AL. RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2 PROMOTE AND STABILIZE HARD AND SOFT TISSUE HEALING FOR LARGE MANDIBULAR NEW BONE RECONSTRUCTION DEFECTS. J CRANIOFAC SURG 2014;25: 860¿862. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7510600, PRODUCT CODE NEK WAS CLEARED IN THE UNITED STATES. (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 7510600, PMA # P000058 WAS CLEARED IN THE UNITED STATES. 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 PATIENT WAS SEEN BY HIS LOCAL DENTIST, WHEN HE DEVELOPED SWELLING IN THE RIGHT MANDIBULAR AREA. THE PANOREX AND COMPUTED TOMOGRAPHY SCAN INVESTIGATION SHOWED A LARGE TISSUE MASS LOCALIZED IN THE RIGHT MANDIBLE. A BIOPSY WAS TAKEN FROM THE LESION, AND HISTOLOGIC REPORT PROVED IT TO BE AN AMELOBLASTOMA TUMOR OF SOLID MULTICYSTIC TYPE. THE PATIENT WAS THEN PLACED INTO A MAXILLOMANDIBULAR FIXATION, AND AN INFERIOR 2.6-MM LOCKING RECONSTRUCTION PLATE WAS CHOSEN FOR THE MANDIBULAR RECONSTRUCTION. A FULL-THICKNESS MUCOPERIOSTEAL INCISION WAS ELEVATED IN THE MUCOSA ALONG THE DEFECT. THE LIMITS OF THE TUMOR HAVE BEEN CLINICALLY RECORDED, AND THE BONE RESECTION WAS PERFORMED ON HEALTHY BONE 1 CM OVER THE TUMOR EXTENSIONS, WHICH TOTALED NEARLY 7.5 CM. ONCE THE UNDERLYING RIDGE WAS EXPOSED, A MESH WAS COUNTERED TO CORRECT THE DEFECT. IT IS IMPORTANT TO OVERCORRECT BY AS MUCH AS 15% TO 20% AS SOME RESORPTION IS EXPECTED. THE UNDERLYING RIDGE IS OVERHAULED WITH A SMALL DRILL TO STIMULATE BLEEDING. THIS ACCOMPLISHES FASTER INTEGRATION OF THE GRAFT AS WELL AS SUPPLYING ADDITIONAL STEM CELLS TO THE AREA. THE RHBMP-2 WAS THEN PLACED ON THE ACS AND THEN MODELED ON THE POSITIONED PLATE. A PORTION OF THE COLLAGEN SPONGE IS THEN CUT INTO SMALL 2- TO 3-MM PIECES AND MIXED THROUGHOUT DEMINERALIZED BONE MATRIX ALLOGRAFT PUTTY. THE RHBMP-2/ACS/ALLOGRAFT WAS PLACED INTO THE MESH AND MODELED ACCORDING TO THE MANDIBLE ANATOMY. NO BONE GRAFT WAS TAKEN FROM EXTRAORAL SITES. THE MESH AND GRAFT MATERIAL WERE THEN SECURED IN PLACE WITH A MINIMUM OF 2 SCREWS, BUT PREFERABLY MORE. COMPUTED TOMOGRAPHY AND ORTHOPANTOMOGRAPHY POSTOPERATIVE WERE PERFORMED. THE POSTOPERATIVE COURSE WAS UNEVENTFUL, AND THE PATIENT WAS PLACED ON SOFT-LIQUID DIET FOR APPROXIMATELY 6 WEEKS. HOWEVER, 1-WEEK CONTROL REVEALED LARGE EDEMA ON THE TREATED AREA. THIS SITUATION WAS RELATED WITH THE POTENTIAL OF RHBMP-2 ON RECALLING INFLAMMATORY CELLS. ON EXAMINATION OF THE PATIENT AT THE 3-MONTH FOLLOW-UP, CLINICAL PALPATION OF THE MUCOSA OVERLYING THE RESECTED AREA SHOWED HARD INDURATED CALCIFYING SURFACE OF THE REGENERATED BONE. THE PATIENT EXHIBITED RADIOGRAPHIC EVIDENCE OF BONE FORMATION AS EARLY AS 3 OR 4 MONTHS POSTOPERATIVELY, AND MANDIBULAR CONTINUITY WAS REGAINED AS DEMONSTRATED BOTH CLINICALLY AND RADIOGRAPHICALLY EVEN AT 18 MONTHS OF FOLLOW-UP CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347513 INDUCTOS NEK MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00031 YR Other