BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1831044 · Received September 7, 2010

    Report

    Report Number
    1030489-2010-01133
    Event Type
    Injury
    Date Received
    September 7, 2010
    Date of Event
    April 5, 2006
    Report Date
    August 18, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    MPW
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LITERATURE CITATION: PERRI, ET AL. ADVERSE SWELLING ASSOCIATED WITH THE USE OF RH-BMP-2 IN ANTERIOR CERVICAL DISCECTOMY AND FUSION: A CASE STUDY. THE SPINE JOURNAL, 2007; 7: 235-239. NEITHER THE DEVICE NOR TEST RESULTS NOR IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVAL. A REVIEW OF THE DEVICE HISTORY RECORDS IS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFO. THEREFORE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT IS REPORTED THE PT PRESENTED TO THE EMERGENCY ROOM IN MODERATE DISTRESS WITH NECK ANTERIOR NECK SWELLING AND DIFFICULTY SWALLOWING. THE PT WAS 5 DAYS STATUS-POST ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) AT C3-C4 AND C4-C5 WITH FIXATION AT C3 TO C5, AUGMENTED BY RH-BMP-2/ACS PLACED INSIDE BIOABSORBABLE INTERBODY GRAFTS. IT IS NOTED THAT A RIGID CERVICAL COLLAR WAS WORN CONTINUOUSLY FOR THE FIVE DAYS POST SURGERY. THERE WAS NO WOUND DEHISCENCE OR ERYTHEMA. MASSIVE NECK SWELLING AND SMALL FLUID COLLECTION WAS EVIDENT IPSILATERAL TO THE SIDE OF THE SURGICAL APPROACH. RADIOGRAPHS AND COMPUTED TOMOGRAPHIC SCAN SHOWED SEVERAL POCKETS OF AIR WITHIN THE SOFT TISSUES. A DISCRETE HEMATOMA WAS NOT PRESENT. THERE WERE NO SIGNS OF CERVICAL HARDWARE FAILURE. THE INTERBODY GRAFTS WERE INTACT WITHOUT SIGNS OF FRACTURE OR DISPLACEMENT. THE PT WAS ADMITTED TO THE INTENSIVE CARE UNIT WHERE PARENTERAL STEROIDS WERE ADMINISTERED FOR 24 HOURS DURING MONITORED INTUBATION. THE PT WAS EXTUBATED ON THE SECOND HOSPITAL DAY AND DISCHARGED HOME ON THE FOURTH HOSPITAL DAY AFTER SWELLING SUBSIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT INFUSE BONE GRAFT MPW MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R ANTERIOR CERVICAL PLATE