BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN DURAL GRAFT

    MDR report key: 7079878 · Received December 4, 2017

    Report

    Report Number
    1835959-2017-00020
    Event Type
    Injury
    Date Received
    December 4, 2017
    Report Date
    December 4, 2017
    Manufacturer
    COOK BIOTECH
    Product Code
    GXQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT WAS A RETROSPECTIVE STUDY OF PATIENTS UNDERGOING SURGICAL TREATMENT FOR TYPE I CHIARI MALFORMATION BETWEEN JUNE 2008 AND JANUARY 2015. LOT NUMBER NOT PROVIDED BY THE COMPLAINANT. PRODUCT EXPIRE DATE UNKNOWN; LOT NUMBER NOT PROVIDED. PRODUCT CATALOG NUMBER UNKNOWN, PRODUCT UNSPECIFIED. IMPLANT DATE NOT PROVIDED BY THE COMPLAINANT. NUMBER 510(K) IS K160869. PRODUCT MANUFACTURE DATE UNKNOWN; LOT NUMBER UNKNOWN. THIS MDR CAPTURES ASEPTIC MENINGITIS OCCURRENCE 5 OF 7. ASEPTIC MENINGITIS IS A CONDITION REFERRING TO INFLAMMATION OF THE MENINGES THAT IS NOT CAUSE BY BACTERIA. A REVIEW OF THE IFU INDICATED THAT ACUTE OR CHRONIC INFLAMMATION WAS NOTED AS ONE OF THE POTENTIAL COMPLICATIONS THAT ARE POSSIBLE WITH THE USE OF SURGICAL GRAFT MATERIALS. A DIRECT ROOT CAUSE, FOR THE OCCURRENCE OF ASEPTIC MENINGITIS, IS INCONCLUSIVE. HOWEVER, ASEPTIC MENINGITIS IS A KNOWN POST-OPERATIVE COMPLICATION ASSOCIATED WITH THE POSTERIOR FOSSA DECOMPRESSION SURGICAL PROCEDURE. FACTORS THAT COULD CONTRIBUTE TO THIS OCCURRENCE INCLUDE BUT ARE NOT LIMITED TO SURGICAL TECHNIQUE, HINDERED HEALING PROCESS (POOR NUTRITIONAL STATE, PRESENCE OF INFECTION, STEROID THERAPY), AND VIRAL INFECTIONS.

    Description of Event or Problem · 1

    HTTP://DX.DOI.ORG/10.1016/J.WNEU.2017.08.061. SEVEN (7) PATIENTS, WHO UNDERWENT POSTERIOR FOSSA DECOMPRESSION SURGERIES FOR CHIARI MALFORMATIONS, "DEVELOPED MENINGITIS, ALL OF WHOM HAD CONFIRMED OR SUSPECTED ASEPTIC MENINGITIS. THERE WERE NO OCCURRENCES OF BACTERIAL MENINGITIS IN THE PORCINE DURAL SUBSTITUTE GROUP." THE AUTHORS NOTED THAT "OF THE TREATMENT CHARACTERISTICS INVESTIGATED, EBL (ESTIMATED BLOOD LOSS) WAS ASSOCIATED WITH A SLIGHTLY GREATER RISK OF MENINGITIS BUT NOT OTHER POSTOPERATIVE COMPLICATIONS." NO ADDITIONAL PATIENT SPECIFIC DETAILS WERE PROVIDED BY THE AUTHORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860034 BIODESIGN DURAL GRAFT DURAL GRAFT GXQ COOK BIOTECH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CASE SPECIFIC DETAILS NOT PROVIDED BY THE AUTHORS.