BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN-UNKNOWN PRODUCT ID

    MDR report key: 7814285 · Received August 24, 2018

    Report

    Report Number
    1121308-2018-00062
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. NO DHR REVIEW IS POSSIBLE SINCE NO LOT NUMBER WAS PROVIDED. THE REPORTED COMPLAINT WAS NOT CONFIRMED. THUS, THE ROOT CAUSE OF THE REPORTED CONDITION IS UNDETERMINED. THIS CAN ALSO BE FOUND ONLINE AT : DOI 10.1007/S00701-014-2263-X.

    Description of Event or Problem · 1

    ACTA NEUROCHIRURGICA (2015) PUBLISHED, "ALLODERM FOR DURAPLASTY IN CHIARI MALFORMATION: SUPERIOR OUTCOMES". THE STUDY AIMS TO COMPARE THE INCIDENCE OF GRAFT-RELATED COMPLICATIONS ASSOCIATED WITH USING ACELLULAR HUMAN DERMIS ALLOGRAFT (ALLODERM) WITH THOSE OF DURAGUARD, DURAGEN, AND DUREPAIR. ALLODERM WAS USED AS THE DURAL GRAFT IN 46 PATIENTS (35.9 %), WHEREAS DURAGUARD AND DUREPAIR WERE USED IN 35 (27.3 %) AND 32 (25.0 %) PATIENTS, RESPECTIVELY. DURAGEN WAS USED IN EIGHT PATIENTS (6.3 %). IN A RETROSPECTIVE COHORT CHART REVIEW, THE COHORT INCLUDED 119 PATIENTS WHO UNDERWENT 128 CHIARI DECOMPRESSION PROCEDURES BY A SINGLE SURGEON FROM JANUARY 1, 1997, THROUGH JULY 31, 2012. DURAL GRAFTS WERE SELECTED BASED ON THE COMMERCIAL PRODUCTS AVAILABLE AT THE TIME OF SURGERY DURING THIS 15-YEAR PERIOD. RESULTS: THE REOPERATION RATE WITH ALLODERM USE WAS 2.2 %, WITH ONLY ONE FAILURE IN 46 CASES, WHILE THE REOPERATION RATE WITH ALL OTHER DURAL GRAFTS WAS 17.1 %, OR 14/82 CASES. DURAGEN HAD A FAILURE RATE OF 12.5 % (1/8 CASES). THE MODE OF GRAFT FAILURE LEADING TO PSEUDOMENINGOCELE OCCURRENCE ALSO DIFFERED CONSIDERABLY AMONG THE ALLOGRAFT MATERIALS. DUREPAIR AND DURAGEN WERE CONSISTENTLY NOTED TO THIN AND DISSOLVE SO THAT HOLES TYPICALLY DEVELOPED IN THE CENTRAL AREA OF THE PATCH, AND THE REMAINING TISSUE WAS TOO FRIABLE TO REPAIR WITH SUTURE OR EVEN PARTIAL PATCH GRAFTING. THERE WERE NO WOUND INFECTIONS, BUT THERE WERE THREE INSTANCES OF ASEPTIC MENINGITIS NECESSITATING WORKUP WITH CSF ANALYSIS BY LUMBAR PUNCTURE AND TREATMENT WITH CORTICOSTEROIDS. THESE OCCURRED IN 5.7 % (2/35) OF DURAGUARD CASES, 12.5 % (1/8) OF DURAGEN CASES, AND DID NOT OCCUR WITH ALLODERM OR DUREPAIR. DURAGEN FAILED IN ITS ONLY USE AS A RESCUE GRAFT. CONCLUSIONS: THE USE OF THE ALLODERM FOR DURAPLASTY WITH CHIARI DECOMPRESSIONS RESULTED IN SIGNIFICANTLY LESS NEED FOR REOPERATIONS (2.2 %) COMPARED WITH THE USE OF OTHER DURAL GRAFTS (17.1 %). THERE WAS NO ASSOCIATION BETWEEN PATIENT AGE, SEX, OBESITY, OR SMOKING STATUS AND THE NEED FOR REOPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656161 DURAGEN-UNKNOWN PRODUCT ID PLAINSBORO GXQ INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1