BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN DURAL GRAFT

    MDR report key: 12104153 · Received July 1, 2021

    Report

    Report Number
    1835959-2021-00003
    Event Type
    Injury
    Date Received
    July 1, 2021
    Report Date
    June 29, 2021
    Manufacturer
    COOK BIOTECH
    Product Code
    GXQ
    UDI-DI
    10827002310923
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT NOT REPORTED BY COMPLAINANT. EXPLANT DATE NOT REPORTED BY COMPLAINANT. 510(K) K160869. INVESTIGATION INTO THIS FEEDBACK INCLUDED: A REVIEW OF THE FEEDBACK DETAILS, A REVIEW OF THE DEVICE LOT HISTORY RECORD, A REVIEW OF THE CBI COMPLAINT DATABASE, AND A REVIEW OF THE BIODESIGN DURAL GRAFT IFU FP0030-01O. A REVIEW OF THE DEVICE LOT HISTORY RECORDS INDICATED THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. THE DEVIATION WOULD NOT HAVE CONTRIBUTED TO THE OCCURRENCE. THE LOT PRODUCED A TOTAL OF (B)(4) DEVICES. THE DEVICE LOT HISTORY RECORDS INDICATE THAT THE (B)(4) DEVICES THAT WERE RELEASED FOR DISTRIBUTION MET THE FINAL INSPECTION SPECIFICATION REQUIREMENTS. A REVIEW OF THE CBI COMPLAINT DATABASE DID NOT REVEAL ANY ADDITIONAL COMPLAINTS INVOLVING THE REPORTED LOT NUMBER. PER THE IFU, THE DEVICE DERIVED FROM A PORCINE SOURCE AND SHOULD NOT BE USED FOR PATIENTS WITH KNOWN SENSITIVITY TO PORCINE MATERIAL. PER THE SURGEON AND BASED ON THE PATHOLOGY RESULTS, THE ROOT CAUSE OF THE PATIENT'S COURSE OF EVENTS WAS DUE TO A FOREIGN BODY REACTION TO THE DEVICE.

    Description of Event or Problem · 1

    PATIENT HAD AN ALLERGIC REACTION. THE GRAFT WAS SUTURED IN WITH A 5-0 PROLENE ON A C-1 NEEDLE. THE CUSTOMER REQUESTED A SMALL SAMPLE TO ATTEMPT TO PIN DOWN THE ALLERGY SOURCE. THE SURGEON REPORTED TO THE COOK AREA REPRESENTATIVE THAT THE PATIENT CAME BACK WITH A SUSPECTED TUMOR RECURRENCE. THE PATIENT WAS REOPERATED ON AND THERE WAS NOT A TUMOR PRESENT, BUT RATHER WHAT APPEARED TO BE AN ALLERGIC REACTION. THE AREA CLEANED UP AND THE SAMPLES WERE SENT FOR TESTING. THE RESULTS DID NOT INDICATE THE REACTION WAS TO BIODESIGN. THE SURGEON USES BIODESIGN OFTEN AND HAS NO CONCERNS. ON 06/29/2021, DR. (B)(6) REPORTED ADDITIONAL DETAILS TO CBI. THE PATIENT'S UNDERLYING CONDITION BEING TREATED WAS A MENINGIOMA. THE BIODESIGN DURAL GRAFT WAS IMPLANTED AS A REPLACEMENT OF THE DURA THAT WAS REMOVED AS PART OF THE TUMOR RESECTION. THE GRAFT WAS FIXED INTO PLACE WITH PROLENE SUTURE. THERE WAS NO CONCURRENT MEDICATIONS AT THE TIME OF GRAFT PLACEMENT OR NEW MEDICATIONS POST-OP. THERE WERE ALSO NO OINTMENTS, CREAMS OR SPECIAL WOUND CARE BANDAGES USED ON THE PATIENT. THE PATIENT UNDERWENT A REPEAT CRANIOTOMY FOR RESECTION OF THE GRAFT. THE PATIENT'S COURSE OF EVENTS WAS DETERMINED TO BE A GRANULOMATOUS REACTION TO FOREIGN BODY. THIS WAS DETERMINED BY A NODULAR CONTRAST-ENHANCEMENT ON MRI, GRANULOMATOUS INFLAMMATION ON PATHOLOGY, NEGATIVE ACID BACILLI AND GROCOTT METHENAMINE SILVER STAINS, AND CD68 HIGHLIGHTS HISTIOCYTIC INFILTRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994475 BIODESIGN DURAL GRAFT DURAL GRAFT GXQ COOK BIOTECH G31092 LB1138407 10827002310923

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention