BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTERGRO DBM PLUS

    MDR report key: 1381767 · Received May 15, 2009

    Report

    Report Number
    2242816-2009-00033
    Event Type
    Death
    Date Received
    May 15, 2009
    Date of Event
    February 3, 2009
    Report Date
    May 14, 2009
    Manufacturer
    EBI, LLC
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED HEREIN IS IN RESPONSE TO THE FDA LETTER DATED MAY 20, 2009 WITH THE REFERENCED REPORT NUMBER 2242816-2009-00033 SENT. ANY EVALUATION OF THE INCIDENT DESCRIBED IN THE MEDICAL DEVICE REPORT BY THE ATTENDING PHYSICIAN, SURGEON, HOSPITAL REPRESENTATIVE OR THE HEALTH CARE PROFESSIONAL. TO DATE, NO NOTIFICATION OF THE EVENT OR EVALUATION PERTAINING TO THIS EVENT HAS BEEN RECEIVED FROM THE INITIAL REPORTER. ANY EVALUATION OF OTHER INFORMATION USED BY YOUR FIRM TO DETERMINE WHETHER THE EVENTS DESCRIBED IN THE MEDICAL DEVICE REPORT ARE OR ARE NOT ATTRIBUTABLE TO THE DEVICE. THE DEVICE HISTORY RECORD WAS REVIEWED AND THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS. PHYSICIAN REVIEW OF THE INCIDENT INDICATES THAT THE REPORTED EVENT IS UNLIKELY ATTRIBUTED TO THE DEVICE. SERIOUS CO-MORBIDITIES IN THIS PATIENT AND A HISTORY OF A SERIOUS UNDERLYING CARDIAC CONDITION ARE THE IMPORTANT CONTRIBUTORY FACTORS. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    PATIENT HAD SURGERY IN LATE 2008, ENDOSCOPIC GASTROCNEMIUS RECESSION OF THE LEFT LEG AND TRIPLE ARTHRODESIS OF THE LEFT FOOT. DISCHARGED HOME. READMISSION TWO WEEKS LATER AFTER FALL AT HOME. LEFT FOOT SURGICAL WOUND INFECTION. PROBABLE SEPSIS FROM URINARY TRACT INFECTION AND MRSA SEPTICEMIA RELATED TO FOOT INFECTION. PATIENT HAD HISTORY OF ATRIAL FIBRILLATION, SEVERE CARDIOMYOPATHY, STATUS POST AICD PLACEMENT IN PAST. EXPERIENCED GI SYSTEM PROBLEMS WITH EMESIS; RESPIRATORY FAILURE AND SUDDEN CARDIAC DEATH TWO WEEKS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERGRO DBM PLUS BONE GRAFT MATERIAL MQV EBI, LLC 932080

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death