BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIODESIGN DURAL GRAFT

    MDR report key: 7079852 · Received December 4, 2017

    Report

    Report Number
    1835959-2017-00014
    Event Type
    Injury
    Date Received
    December 4, 2017
    Report Date
    December 1, 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 PSEUDOMENINGOCELE OCCURRENCE REQUIRING REOPERATION 5 OF 6. A REVIEW OF THE IFU INDICATED THAT CSF LEAK 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 PSEUDOMENINGOCELE, IS INCONCLUSIVE. HOWEVER, PSEUDOMENINGOCELE 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, UNDERLYING PATIENT COMORBIDITIES, HINDERED HEALING PROCESS (POOR NUTRITIONAL STATE, PRESENCE OF INFECTION, STEROID THERAPY), PUNCTURES TO THE DURA SAC AS THE RESULT OF RESIDUAL BONE FRAGMENTS, AND THE PATIENT'S POST-OPERATIVE ACTIVITY (COUGHING, VOMITING, STRAINING). H3 OTHER TEXT : B3) 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 PSEUDOMENINGOCELE OCCURRENCE REQUIRING REOPERATION 5 OF 6. A REVIEW OF THE IFU INDICATED THAT CSF LEAK 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 PSEUDOMENINGOCELE, IS INCONCLUSIVE. HOWEVER, PSEUDOMENINGOCELE 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, UNDERLYING PATIENT COMORBIDITIES, HINDERED HEALING PROCESS (POOR NUTRITIONAL STATE, PRESENCE OF INFECTION, STEROID THERAPY), PUNCTURES TO THE DURA SAC AS THE RESULT OF RESIDUAL BONE FRAGMENTS, AND THE PATIENT'S POST-OPERATIVE ACTIVITY (COUGHING, VOMITING, STRAINING).

    Description of Event or Problem · 1

    HTTP://DX.DOI.ORG/10.1016/J.WNEU.2017.08.061. TWELVE (12) PATIENTS, WHO UNDERWENT POSTERIOR FOSSA DECOMPRESSION SURGERIES FOR CHIARI MALFORMATIONS, DEVELOPED POST-OPERATIVE "SYMPTOMATIC PSEUDOMENINGOCELES. THREE OF THE PATIENTS WITH PSEUDOMENINGOCELES ALSO PRESENTED WITH EXTERNAL CSF LEAKS. SIX PATIENTS WITH PSEUDOMENINGOCELES UNDERWENT REPEAT OPERATIONS FOR REVISION OF DURAPLASTY AS A RESULT OF FAILURE OF SYMPTOMS TO RESOLVE WITH NONOPERATIVE MANAGEMENT (STEROIDS, LUMBAR DRAIN). THREE OF THESE REPEAT OPERATIONS ALSO INVOLVED PLACEMENT OF VENTRICULOPERITONEAL SHUNT FOR HYDROCEPHALUS." NO ADDITIONAL PATIENT SPECIFIC DETAILS WERE PROVIDED BY THE AUTHORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859387 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.