BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUREPAIR DURA SUBSTITUTE

    MDR report key: 5345725 · Received January 5, 2016

    Report

    Report Number
    2021898-2015-00483
    Event Type
    Injury
    Date Received
    January 5, 2016
    Report Date
    November 20, 2015
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GXQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THESE EVENTS WERE IDENTIFIED DURING REVIEW OF SCIENTIFIC LITERATURE. THE ARTICLE CONTAINED ONLY LIMITED AND NON-SPECIFIC DEVICE INFORMATION. CONTACT WITH THE CORRESPONDING AUTHOR HAS BEEN UNSUCCESSFUL IN YIELDING ADDITIONAL DEVICE INFORMATION. THE EVENTS REPORTED IN THE SOURCE LITERATURE COULD NOT BE MATCHED TO INFORMATION PREVIOUSLY REPORTED TO MEDTRONIC NEUROSURGERY. THE PRODUCTS WERE UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBERS WERE PROVIDED. LITERATURE ARTICLE: ALLODERM FOR DURAPLASTY IN CHIARI MALFORMATION: SUPERIOR OUTCOMES AUTHORS: CHRISTIAN A. BOWERS <(>&<)> CAMERON BRIMLEY <(>&<)> CHAD COLE <(>&<)> WAYNE GLUF <(>&<)> RICHARD H. SCHMIDT ACTA NEUROCHIR (2015) 157:507¿511 DOI 10.1007/S00701-014-2263-X.(B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED BY MEDTRONIC NEUROSURGERY UPON REVIEW OF SCIENTIFIC LITERATURE: DURING THE STUDY PERIOD, 150 PATIENTS UNDERWENT 167 PROCEDURES, BUT THE FINAL COHORT CONSISTED OF 119 PATIENTS THAT UNDERWENT 128 PROCEDURES. DUREPAIR WAS USED WITH 32 PATIENTS. DUREPAIR HAD A FAILURE RATE OF 21.9 % (7/32 CASES). DUREPAIR AND ANOTHER MANUFACTURER'S PRODUCT 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 OR ASEPTIC MENINGITIS WITH DUREPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3667 DUREPAIR DURA SUBSTITUTE DURA SUBSTITUTE GXQ MEDTRONIC NEUROSURGERY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00034 YR