BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 2221400 · Received August 24, 2011

    Report

    Report Number
    1030489-2011-01093
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    July 26, 2011
    Report Date
    August 1, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NEK
    PMA / PMN Number
    P000054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE CITATION: JULKA ET AL. INFLAMMATORY RESPONSE TO RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2 USE IN THE TREATMENT OF A PROXIMAL HUMERAL FRACTURE: A CASE REPORT. J SHOULDER ELBOW SURG 2011; E1-E5. (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. A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LITERATURE PUBLICATION THAT THE PATIENT PRESENTED WITH A MINIMALLY DISPLACED, COMMINUTED FRACTURE OF THE RIGHT PROXIMAL HUMERUS THROUGH THE SURGICAL NECK. SHE ELECTED NONOPERATIVE MANAGEMENT AFTER AN INFORMED DISCUSSION REGARDING THE RISKS AND BENEFITS OF TREATMENT ALTERNATIVES. BECAUSE OF PERSISTENT PAIN 5 MONTHS AFTER THE INJURY, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED NONUNION. THE PATIENT UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION OF THE NONUNION AND AUGMENTATION OF THE BIOLOGIC ENVIRONMENT WITH RHBMP-2EIMPREGNATED COLLAGEN SPONGES APPLIED CIRCUMFERENTIALLY TO THE NONUNION SITE. SHE WAS DISCHARGED ON POSTOPERATIVE DAY (POD) 1, AFTER AN UNREMARKABLE PERIOPERATIVE COURSE. SHE RETURNED TO CLINIC ON POD 4 WITH MARKED EDEMA OF HER SHOULDER AND CHEST WALL, AND MODERATE SWELLING OF THE FOREARM AND HAND. THE SKIN ADJACENT TO THE OPERATIVE SITE WAS SHINY AND ERYTHEMATOUS. AN ULTRASOUND DEMONSTRATED NO EVIDENCE OF SIGNIFICANT HEMATOMA, BUT THE STUDY COULD NOT DEFINITIVELY EXCLUDE DEEP VENOUS THROMBOSIS. BECAUSE OF THE UNUSUAL CLINICAL PICTURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL. A VENOGRAM DEMONSTRATED EXTERNAL COMPRESSION OF THE AXILLARY VEIN TO APPROXIMATELY 10% OF ITS NORMAL DIAMETER AT THE LEVEL OF THE PROXIMAL HUMERUS. A CT SCAN REVEALED NO EVIDENCE OF A SIGNIFICANT HEMATOMA, BUT RATHER DIFFUSE SOFT TISSUE EDEMA IN THE SHOULDER AND CHEST WALL, RESULTING IN COMPRESSION OF THE AXILLARY VEIN. BECAUSE THE MOST COMMON CAUSES OF POSTOPERATIVE UPPER EXTREMITY SWELLING INCLUDING INFECTION, HEMATOMA, AND DEEP VENOUS THROMBOSIS WERE EXCLUDED, THE AUTHORS HYPOTHESIZED THAT THE SOFT TISSUE EDEMA WAS DUE TO AN RHBMP-2 MEDIATED INFLAMMATORY REACTION. THE IMMUNOLOGY CONSULTATION SERVICE CONCURRED, AND RECOMMENDED TREATMENT WITH INTRAVENOUS CORTICOSTEROIDS, FOLLOWED BY AN ORAL PREDNISONE TAPER. THIS TREATMENT WAS INITIATED, AND THERE WAS A DRAMATIC IMPROVEMENT IN SWELLING AFTER THE FIRST DOSE OF INTRAVENOUS CORTICOSTEROID, FOLLOWED BY A SLOW AND GRADUAL RESOLUTION OVER SEVERAL WEEKS. OF NOTE, AFTER CONSULTATION WITH VASCULAR SURGERY, THE PHYSICIANS INITIATED THERAPEUTIC ANTICOAGULATION UNTIL EDEMA SUBSIDED TO PREVENT SECONDARY DEVELOPMENT OF AXILLARY VEIN THROMBOSIS. DURING THE NEXT 3 MONTHS, RADIOGRAPHS DEMONSTRATED PROGRESSIVE DEVELOPMENT OF HETEROTOPIC OSSIFICATION (HO) ADJACENT TO THE FRACTURE SITE AND IN THE CHEST WALL. THE PATIENT'S SHOULDER MOTION STEADILY PROGRESSED TO NEAR FULL RANGE OF MOTION AT 3 MONTHS. IMAGING REVEALED OSSEOUS HEALING BY 4 MONTHS. THE COMPLICATIONS THE AUTHORS ATTRIBUTE TO RHBMP-2 USE IN THIS PATIENT ARE EXAGGERATED INFLAMMATORY REACTION, SECONDARY AXILLARY VEIN COMPRESSION, AND HO.

    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 00058 YR Hospitalization| R