BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUREPAIR DURA SUBSTITUTE

    MDR report key: 2496423 · Received March 15, 2012

    Report

    Report Number
    2021898-2012-00047
    Event Type
    Injury
    Date Received
    March 15, 2012
    Date of Event
    February 13, 2012
    Report Date
    February 14, 2012
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GXQ
    PMA / PMN Number
    K041000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DUREPAIR WAS RETURNED AS A STRIP ABOUT 4 INCHES LONG. THE MATERIAL HAD VARYING WIDTHS AND THICKNESSES. THE EDGES OF THE MATERIAL CURLED AWAY IN BOTH DIRECTIONS FROM THE CENTER. THE COLOR OF THE MATERIAL WAS A SEMI-OPAQUE WHITISH-PURPLE. ONE EDGE HAD SEVERAL SUTURES STILL ATTACHED TO THE MATERIAL, WHILE ON THE OTHER EDGE NO SUTURES WERE PRESENT. THIS SUGGESTS THAT THE SUTURED EDGE OF THE MATERIAL WAS THE EDGE THAT FORMED THE OUTER CIRCUMFERENCE OF THE IMPLANTED DUREPAIR, AND THE EDGE WITHOUT SUTURES WAS THE CENTER OF THE GRAFT WHERE THE HOLE WAS SAID TO BE PRESENT. THIS EDGE WAS ALSO THINNER ON AVERAGE THAN THE EDGE WITH THE SUTURES, WHICH IS ALSO CONSISTENT WITH THE CLAIM THAT THE DISINTEGRATION WAS PRESENT AT THE CENTER OF THE GRAFT. CLEAR, GELATINOUS-TEXTURED MATERIAL WAS PRESENT ON ONE SIDE OF THE DUREPAIR. AS IT WAS CONFIRMED THAT DURASEAL WAS USED IN CONJUNCTION WITH THE DUREPAIR, THIS MATERIAL MAY BE DURASEAL. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTION THAT THE FOREIGN BODY RESPONSE ASSOCIATED WITH THE USE OF SEALANTS AND HEMOSTATIC AGENTS IN CONJUNCTION WITH DUREPAIR MAY BE MORE PRONOUNCED THAN USE OF DUREPAIR ALONE. THIS RESPONSE MAY INCREASE THE INCIDENT RATES OF KNOWN RISKS OF DURA SUBSTITUTES (INCLUDING CSF LEAKS), PARTICULARLY IN HIGH PRESSURE GRADIENT APPLICATIONS. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. NO INJURY TO THE PATIENT WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE DOCTOR BELIEVED THAT THERE MAY HAVE BEEN A LEAK IN THE DUREPAIR IMPLANTED ON THE PATIENT'S SPINE. ACCORDING TO THE REPORT, WHEN THE DUREPAIR WAS EXPLANTED, THE DOCTOR NOTICED A LARGE HOLE IN THE CENTER OF THE GRAFT. IT WAS DESCRIBED THAT THE CENTER OF THE DUREPAIR HAD DISINTEGRATED. THE DOCTOR HAD USED DURASEAL IN CONJUNCTION WITH THE DUREPAIR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R