BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN DURAL GRAFT

    MDR report key: 7490532 · Received May 7, 2018

    Report

    Report Number
    1835959-2018-00008
    Event Type
    Injury
    Date Received
    May 7, 2018
    Report Date
    May 7, 2018
    Manufacturer
    COOK BIOTECH
    Product Code
    GXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT NOT PROVIDED BY THE COMPLAINANT. LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. PRODUCT EXPIRE DATE UNKNOWN; LOT NUMBER NOT PROVIDED IMPLANT DATE NOT PROVIDED BY THE COMPLAINANT THE 510(K) K160869. PRODUCT MANUFACTURE DATE UNKNOWN; LOT NUMBER UNKNOWN. A REVIEW OF THE IFU REVEALED THAT "ACUTE OR CHRONIC INFLAMMATION" IS LISTED AMONGST THE POTENTIAL COMPLICATIONS. ADDITIONALLY, "INITIAL APPLICATION OF SURGICAL GRAFT MATERIALS MAY BE ASSOCIATED WITH TRANSIENT, MILD, LOCALIZED INFLAMMATION." A ROOT CAUSE, FOR THE REPORTED INFLAMMATION, IS INCONCLUSIVE DUE TO A LACK OF DETAILS PROVIDED BY THE COMPLAINANT. THE REPORTED SECONDARY EFFECTS (SEIZURE, EDEMA, NEED FOR A SHUNT) OF THE INFLAMMATION ARE ALSO KNOWN POTENTIAL COMPLICATIONS OF THE SURGICAL PROCEDURE, WITH OR WITHOUT THE IMPLANTATION OF THE BIODESIGN DURAL GRAFT. THE COMPLAINT FILE WILL BE UPDATED AND A FOLLOW-UP MDR WILL BE FILED SHOULD ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    DR. (B)(6) REPORTED SEEING AN INFLAMMATORY RESPONSE, IN THE BRAIN, IN MULTIPLE PATIENTS. THIS IS AFTER THE USE OF THE BIODESIGN DURAL GRAFT IN CRANIOTOMIES, POSTERIOR FOSSA CASES, ETC. THE PATIENTS HAVE EXPERIENCED SEIZURE, EDEMA, AND ONE PATIENT NEEDED A SHUNT PLACED. ALSO, SIX TO EIGHT ADDITIONAL WEEKS OF ANTIBIOTICS HAD TO BE PRESCRIBED. DR. (B)(6) REQUESTED FOLLOW-UP FROM CBI. MULTIPLE CONTACT ATTEMPTS WERE MADE TO COMMUNICATE WITH DR. (B)(4). NO RESPONSE WAS RECEIVED. THIS MDR IS BEING FILED FOR THE ONE INSTANCE OF A PATIENT HAVING A SHUNT PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332674 BIODESIGN DURAL GRAFT DURAL GRAFT GXQ COOK BIOTECH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention NONE WERE REPORTED BY THE COMPLAINANT.