BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN-UNKNOWN PRODUCT ID

    MDR report key: 7812803 · Received August 24, 2018

    Report

    Report Number
    1121308-2018-00087
    Event Type
    Injury
    Date Received
    August 24, 2018
    Report Date
    July 31, 2018
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    GXQ
    PMA / PMN Number
    K982180
    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 CORRESPOND TO A STUDY THAT PERFORMED A RETROSPECTIVE EVALUATION. BASED ON THE ABSENCE OF LOT AND CATALOG INFORMATION OF THE PRODUCTS USED DURING THE RETROSPECTIVE EVALUATION BETWEEN JANUARY 2004 AND APRIL 2006, 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 REPORTED CONDITION IS UNCONFIRMED. ADDITIONAL INFORMATION FROM THE MEDICAL CONSULTANT OF INTEGRA INDICATED THE FOLLOWING: ¿THE CONTRAINDICATIONS SECTION OF THE DURAGEN IFU SAYS THAT IT IS NOT RECOMMENDED FOR RECONSTRUCTION OF LARGE SKULL BASE DEFECTS, SO THIS REPRESENTS OFF-LABEL USE.¿ THUS, THE REPORTED CONDITIONS ARE UNRELATED TO THE DURAGEN PRODUCTS.

    Description of Event or Problem · 1

    JOURNAL OF NEUROSURGERY (2007) PUBLISHED "SKULL BASE RECONSTRUCTION IN THE EXTENDED ENDOSCOPIC TRANSSPHENOIDAL APPROACH FOR SUPRASELLAR LESIONS". OBJECT: EXTENDED TRANSSPHENOIDAL APPROACH TO THE SUPRASELLAR REGION HAS THE ADVANTAGES OF MINIMAL INVASIVENESS AND BRAIN MANIPULATION IN SMALL - MEDIUM LESIONS, BUT CARRIES HIGHER RISK OF POSTOPERATIVE CSF LEAK & RELATED COMPLICATIONS THAN THOSE FOR THE STANDARD TRANSSPHENOIDAL APPROACH. EFFECTIVE RECONSTRUCTION OF LARGE SKULL BASE DEFECTS IS A MAJOR CONCERN IN SUCH EXTENDED APPROACHES AND REMAINS CHALLENGING. METHODS: BETWEEN JANUARY 2004 AND APRIL 2006, 21 PATIENTS W/DIFFERENT SUPRASELLAR LESIONS UNDERWENT EXTENDED ENDOSCOPIC ENDONASAL TRANSTUBERCULUM-TRANSPLANUM APPROACH. THREE DIFFERENT TECHNIQUES WERE USED FOR SKULL BASE RECONSTRUCTION. ALL CASES USED DEHYDRATED HUMAN PERICARDIUM (TUTOPLAST) FOR DURAL AND A COPOLYMER OF L-LACTIC ACID AND GLYCOLIC ACID (LACTOSORB) AS A BONE SUBSTITUTE. COLLAGEN SPONGES, FIBRIN GLUE AND AN INFLATED FOLEY BALLOON CATHETER WERE ALSO USED TO FILL THE SPHENOID SINUS CAVITY. ADVERSE EVENTS: TWO (2) POSTOPERATIVE CSF LEAKS (9.5%); ONE (1) MYCOTIC SINUSITIS (4.8%) FOLLOWING INTRADURAL (INLAY) & INTRAEXTRADURAL (INLAY-OVERLAY); NO MENINGITIS OR OTHER COMPLICATIONS RELATED TO THE CLOSURE; NO CASES OF POSTOPERATIVE CSF LEAKAGE OCCURRED IN CASES IN WHICH EXTRADURAL-ONLY RECONSTRUCTION PROCEDURE WAS APPLIED. CONCLUSION: POSTOPERATIVE CSF LEAKAGE RATE AFTER EXTENDED APPROACH TO SUPRASELLAR AREA IS HIGHER COMPARED WITH THAT FOLLOWING STANDARD PITUITARY SURGERY. RECONSTRUCTION AFTER CRANIOPHARYNGIOMA SURGERY EXPOSES PATIENTS TO AN INCREASED RISK OF POSTOPERATIVE CSF LEAKS. EXTRADURAL (OVERLAY) TECHNIQUE WAS FOUND TO BE THE MOST EFFECTIVE IN ASSURING A WATERTIGHT CLOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656077 DURAGEN-UNKNOWN PRODUCT ID PLAINSBORO GXQ INTEGRA LIFESCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1