BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN-UNKNOWN PRODUCT ID

    MDR report key: 7812769 · Received August 24, 2018

    Report

    Report Number
    1121308-2018-00036
    Event Type
    Injury
    Date Received
    August 24, 2018
    Report Date
    July 31, 2018
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    GXQ
    PMA / PMN Number
    K982180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURE ANALYSIS WAS NOT POSSIBLE BECAUSE THE COMPLAINT UNIT WILL NOT BE RETURNED FOR EVALUATION. BASED ON THE ABSENCE OF LOT AND CATALOG INFORMATION OF THE PRODUCTS USED DURING THE RETROSPECTIVE EVALUATION BETWEEN JANUARY 2002 AND JUNE 2011 IT IS UNABLE TO IDENTIFY THE MANUFACTURING TIME FRAME TO BE REVIEWED AND THEREFORE, WAS NOT POSSIBLE TO PERFORM THE DHR REVIEW AND EVENT/NC/CAPA/SCAR HISTORY REVIEW. THE COMPLAINT REPORTED CANNOT BE CONFIRMED. ROOT CAUSE CANNOT BE NOT DETERMINED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    SURGICAL NEUROLOGY INTERNATIONAL (2013) PUBLISHED "THE NEED IN DURAL GRAFT SUTURING IN CHAIRI I MALFORMATION DECOMPRESSION: A PROSPECTIVE, SINGLE-BLIND, RANDOMIZED TRIAL COMPARING SUTURED AND SUTURELESS DURAPLASTY MATERIALS" IN WHICH THIS STUDY COMPARED THE USE OF TWO COMMONLY UTILIZED DURAL CLOSURE TECHNIQUES IN AUGMENTATION DURAPLASTY FOR CHIARI MALFORMATION I (CM I) AND EVALUATED THEIR EFFICACY AND OUTCOME IN TERMS OF QUALITY OF LIFE ASSESSMENTS. THIS PROSPECTIVE RANDOMIZED STUDY COMPARED SUTURELESS (DURAGEN) AND SUTURABLE (DURA-GUARD) TECHNIQUES IN CM I DECOMPRESSION. CLINICAL PARAMETERS, COST ANALYSIS, AND SF-36 QUALITY OF LIFE QUESTIONNAIRE (QLQ) WERE UTILIZED TO ASSESS OUTCOME. AFTER AN ADEQUATE INTRADURAL DECOMPRESSION, THE DURAPLASTY WAS PERFORMED WITH EITHER DURAGEN OR DURA-GUARD DEPENDING ON RANDOMIZATION. DURA-GUARD PATCHES WERE SUTURED TO THE NATIVE DURA IN A WATERTIGHT FASHION USING 4-0 NUROLON RUNNING NONLOCKING SUTURE, WHEREAS DURAGEN WAS LACED OVER THE DURAL OPENING WITHOUT ANY SUTURES OR GLUE. IN MOST CASES, DURAGEN WAS TUCKED UNDER THE NATIVE DURA. RESULTS: THE STUDY WAS CONDUCTED OVER THE PERIOD OF 2002-2011. SIXTEEN PATIENT WERE RANDOMIZED TO DURAGEN AND 18 WERE RANDOMIZED TO DURA-GUARD. NO SIGNIFICANT DIFFERENCE WAS FOUND BETWEEN THE TWO TREATMENT GROUPS FOR POSTOPERATIVE COMPLICATION PARAMETERS: PRESENCE OF COMPLICATIONS, PSEUDOMENINGOCELE, MENINGITIS, CSF LEAK, OTHER COMPLICATIONS, READMISSIONS, OR ER VISITS AND NO PATIENT HAD A WOUND INFECTION. OF THE PATIENTS STUDIED, 20.6% WERE READMITTED FOR COMPLICATIONS RELATED TO DECOMPRESSION. OF THE COMMON COMPLICATIONS ASSOCIATED WITH POSTERIOR FOSSA DECOMPRESSION SURGERY FOR CM I: MENINGITIS OCCURRED IN 9% OF THE PATIENTS, PSEUDOMENINGOCELE OCCURRED IN 26.5%, CSF LEAK OCCURRED IN 5.9%, AND NO PATIENTS EXPERIENCED A WOUND INFECTION. THERE WAS A CLEAR DIFFERENCE IN INCIDENCE OF SOME COMPLICATIONS: MENINGITIS OCCURRED IN 1/16 PATIENTS WITH DURAGEN GROUP AND 2/18 IN DURAGUARD, CSF LEAK HAPPENED IN 2/16 OF DURAGEN PATIENTS AND 0/18 OF DURA-GUARD, AND RADIOGRAPHIC PSEUDOMENINGOCELE IN 6/16 OF DURAGEN AND 6/18 DURA-GUARD PATIENTS. READMISSIONS WERE OBSERVED IN 7/16 DURAGEN PATIENTS AND 0/18 DURA-GUARD PATIENTS. CONCLUSION: BOTH TECHNIQUES ARE EFFECTIVE IN REACHING THE GOALS OF DECOMPRESSION SURGERY FOR CM I AND DID NOT DIFFER IN QUALITY OF LIFE AT FINAL SURVEY. ALL PATIENTS SHOWED SIGNIFICANT IMPROVEMENT IN PHYSICAL FUNCTION, PHYSICAL HEALTH, AND OUTCOME FOLLOWING SURGERY. WITH ALL VARIABLES BEING EQUAL THE CHOICE OF DURAPLASTY MATERIAL MAY BE BASED UPON SURGEON'S PREFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655392 DURAGEN-UNKNOWN PRODUCT ID PLAINSBORO GXQ INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1