BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN DURAL GRAFT

    MDR report key: 8613261 · Received May 15, 2019

    Report

    Report Number
    1835959-2019-00002
    Event Type
    Injury
    Date Received
    May 15, 2019
    Date of Event
    April 22, 2019
    Report Date
    May 15, 2019
    Manufacturer
    COOK BIOTECH
    Product Code
    GXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT #: LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. EXPIRATION DATE: PRODUCT EXPIRE DATE UNKNOWN; LOT NUMBER NOT PROVIDED. CATALOG #: PRODUCT CATALOG NUMBER UNKNOWN, PRODUCT UNSPECIFIED. PMA/510K: K160869. MANUFACTURE DATE: PRODUCT MANUFACTURE DATE UNKNOWN; LOT NUMBER NOT PROVIDED. DEVICE LOT HISTORY RECORDS WERE NOT ABLE TO REVIEWED DUE TO THE COMPLAINANT NOT REPORTING THE LOT NUMBER. THE DEVICE RPN WAS ALSO NOT REPORTED. HOWEVER, THE PROCEDURE WAS A SKULL BASE PROCEDURE AND THE BIODESIGN DURAL GRAFT IS SOLD IN KOREA. THE COMPLAINANT ALSO MENTIONED THE DEVICE WAS A 4-LAYER DEVICE; AS IS THE DURAL GRAFT. PRESUMABLY A BIODESIGN DURAL GRAFT WAS USED IN THIS CASE. THE IFU LISTS CSF LEAK AMONGST THE POTENTIAL COMPLICATIONS. THE ROOT CAUSE, OF THE HOLE IN THE GRAFT, IS INCONCLUSIVE. HOWEVER, BASED ON A REVIEW OF THE PHOTOS PROVIDED BY THE COMPLAINANT, THE HOLE DID NOT APPEAR TO BE DUE TO DEGRADATION OF THE GRAFT. THE HOLE APPEARED TO BE THE RESULT OF CUTTING OR PUNCTURING. IT IS POSSIBLE THAT THE HOLE WAS THE RESULT OF A DRAINAGE CATHETER OR UNINTENTIONAL CUTTING OF THE GRAFT DURING PLACEMENT OR REOPERATION. THE CSF LEAK IS A KNOWN POTENTIAL COMPLICATION OF THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    DR. (B)(6) IMPLANTED A BIODESIGN DURAL GRAFT, ON (B)(6) 2019, FOR A SKULL BASE SURGERY FOR A BRAIN TUMOR. THE GRAFT WAS HYDRATED PRIOR TO PLACEMENT. A DRAINAGE CATHETER WAS PLACED, BUT THE SURGEON COULD NOT RECALL THE LOCATION OF PLACEMENT. THE PATIENT THEN PRESENTED WITH A CSF (CEREBROSPINAL FLUID) LEAK. DR. (B)(6) REOPERATED, ON (B)(6) 2019, AND FOUND THERE WAS A HOLE IN THE MIDDLE OF THE BIODESIGN PRODUCT. THE CSF WAS LEAKING FROM THE HOLE. A COMPETITOR'S PRODUCT WAS SUTURED TO THE HOLE IN THE BIODESIGN. ON (B)(6) 2019, DR. (B)(6) (WITH (B)(6)) INDICATED THE PATIENT WAS IN THE HOSPITAL AND WAS NOT HAVING ANY PROBLEMS. THE ADDITIONAL GRAFT ADDED TO THE BIODESIGN STOPPED THE CSF LEAK. DR. (B)(6) INDICATED HE HAD NOT SEEN THIS IN 10 YEARS OF BIODESIGN EXPERIENCE. HOWEVER, DEPENDING ON THE PATIENT, THE RATE OF REMODELING VARIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407198 BIODESIGN DURAL GRAFT DURAL GRAFT GXQ COOK BIOTECH UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention A DRAINAGE CATHETER WAS PLACED.