BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN-UNKNOWN PRODUCT ID

    MDR report key: 7812798 · Received August 24, 2018

    Report

    Report Number
    1121308-2018-00044
    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

    NO COMPLAINT UNIT WILL BE RETURNED AND NO FAILURE ANALYSIS IS POSSIBLE SINCE THIS COMPLAINT CORRESPONDS TO A REPORT OF 3 CASES PRIOR TO (B)(4) 2006 ON THE USE OF RESORBABLE COLLAGEN DURAL SUBSTITUTES IN THE PRESENCE OF CRANIAL AND SPINAL INFECTIONS PUBLISHED IN 2008. BASED ON THE ABSENCE OF LOT AND CATALOG INFORMATION OF THE PRODUCTS, IT IS NOT POSSIBLE TO IDENTIFY THE MANUFACTURING TIME FRAME TO BE REVIEWED AND THEREFORE, IT WAS NOT POSSIBLE TO PERFORM THE DHR REVIEW AND EVENT/NC/CAPA/SCAR HISTORY REVIEW. THE REPORTED CONDITION IS UNCONFIRMED. THE STUDY CONCLUDES THAT: RESORBABLE COLLAGEN DURAL GRAFTS APPEAR TO BE EFFECTIVE ALTERNATIVES TO EITHER PRIMARY DURAL CLOSURE OR THE USE OF AUTOLOGOUS-HARVESTED TISSUE GRAFTS IN THE SETTING OF GROSSLY CONTAMINATED OR INFECTED WOUNDS. THEREFORE, THE ROOT CAUSE IS NOT RELATED TO DURAGEN PRODUCT.

    Description of Event or Problem · 1

    SURGICAL NEUROLOGY (2008) PUBLISHED THE "USE OF RESORBABLE COLLAGEN DURAL SUBSTITUTES IN THE PRESENCE OF CRANIAL AND SPINAL INFECTIONS". VARIOUS ALLOGRAFTS, XENOGRAFTS, AND SYNTHETIC MATERIALS ARE USED IN NEUROSURGERY TO REPAIR DURAL DEFECTS WHEN PRIMARY SUTURE CLOSURE IS IMPOSSIBLE AND AUTOLOGOUS GRAFTS ARE INADEQUATE OR INACCESSIBLE. WHEN USED IN CONTAMINATED OR INFECTED WOUNDS, HOWEVER, NONAUTOLOGOUS GRAFTS PROMOTE CHRONIC COLONIZATION AND RECURRING INFECTION. RECENTLY, SEVERAL RESORBABLE DURAL SUBSTITUTES THAT ARE BROKEN DOWN BIOLOGICALLY AND REPLACED BY AUTOLOGOUS TISSUES HAVE BEEN INTRODUCED. THESE INCLUDE TYPE 1 COLLAGEN MATRIX (DURAGEN) AND A COLLAGEN IMPLANT DERIVED FROM BOVINE SKIN (DUREPAIR, MEDTRONIC, INC,), WHICH CAN BE APPLIED AS SUTURED OR SUTURELESS ONLAY GRAFTS. THE SAFETY AND EFFICACY OF THIS MATERIAL HAS NOT BEEN REPORTED IN THE SETTING OF WOUND CONTAMINATION OR INFECTION. THE AUTHORS PRESENTED 3 CASES IN WHICH THESE NEW COLLAGEN DURAL SUBSTITUTES WERE SUCCESSFULLY USED TO CLOSE DURAL DEFECTS IN THE PRESENCE OF WOUND CONTAMINATION AND INFECTION. COMPLICATION: A (B)(6) MALE WHO SUSTAINED EXTENSIVE CRANIOCEREBRAL TRAUMA CONSEQUENT TO AN ALL-TERRAIN VEHICLE ACCIDENT UNDERWENT SURGERY FOR WOUND DEBRIDEMENT AND CLOSURE. DURAGEN 5 X 7 CM WAS PLACED OVER THE DEFECT IN THE DURA MATER WITHOUT SUTURES. THREE WEEKS AFTER SURGERY, WOUND DEHISCENCE WITH PURULENT DISCHARGE DEVELOPED, ALONG WITH AN ELEVATED ESR THAT PEAKED AT 50 MM/H, ALTHOUGH THE WBC COUNT WAS NORMAL. CULTURES OF THE PURULENT EXUDATE WERE POSITIVE FOR BOTH CANDID ALBICANS AND METHICILLIN-SENSITIVE S. AUREUS. CT SCAN SHOWED A COLLECTION OF AIR AND FLUID IN THE SUBGALEAL SPACE WITH A PERIPHERAL RIM OF CONTRAST ENHANCEMENT SUGGESTING THE DEVELOPMENT OF AN ABSCESS. SURGICAL DEBRIDEMENT WAS PERFORMED A SECOND TIME. THE PREVIOUSLY PLACED DURAGEN COLLAGEN MATRIX PROVIDED A CONTINUOUS LAYER COVERING THE BRAIN EXCEPT FOR A SINGLE DEFECT MEASURING 3 CM IN DIAMETER. THERE WAS NO PUS BENEATH THE DURAGEN, ONLY DEVITALIZED BRAIN TISSUE. A SECOND PIECE OF DURAGEN COLLAGEN MATRIX WAS PLACED OVER THE DURAL DEFECT DIRECTLY OVER THE PREVIOUSLY PLACED IMPLANT. AFTER AN 8-WEEK COURSE OF ANTIBIOTICS WAS COMPLETED, THE INFECTION WAS COMPLETELY RESOLVED. THE PATIENT UNDERWENT SURGERY 1 YEAR LATER FOR A CRANIOPLASTY. AT THAT TIME, THE SURFACE OF THE BRAIN WAS COVERED BY A CONTINUOUS SHEET OF WELL-VASCULARIZED FIBROUS TISSUE. THE INTERFACE BETWEEN THE DURAGEN IMPLANT AND THE NATIVE DURA MATERE COULD NOT BE DISTINGUISHED. THE PATIENT RETURNED TO WORK FULL TIME, AND HE SHOWED NO SIGNS OF INFECTION 2 YEARS AFTER INJURY. CONCLUSION: RESORBABLE COLLAGEN DURAL GRAFTS APPEAR TO BE EFFECTIVE ALTERNATIVES TO EITHER PRIMARY DURAL CLOSURE OR THE USE OF AUTOLOGOUS-HARVESTED TISSUE GRAFTS IN THE SETTING OF GROSSLY CONTAMINATED OR INFECTED WOUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655861 DURAGEN-UNKNOWN PRODUCT ID PLAINSBORO GXQ INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR