BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAGEN PLUS 3X3 SINGLE

    MDR report key: 884151 · Received July 24, 2007

    Report

    Report Number
    1121308-2007-00008
    Event Type
    Injury
    Date Received
    July 24, 2007
    Date of Event
    February 15, 2007
    Report Date
    July 24, 2007
    Manufacturer
    INTEGRA LIFESCIENCES
    Product Code
    GXQ
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA LIFESCIENCES CORPORATION IS FILING THIS MDR BECAUSE OUR PRODUCT WAS IDENTIFIED AS BEING USED IN ASSOCIATED INCIDENT. AS TWO DURA REPLACEMENTS ARE IDENTIFIED IN THE REPORT, THE REPORTING FACILITY HAS BEEN CONTACTED FOR CLARIFICATION OF THE ACTUAL DEVICE USED. THE PRODUCT IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    ON JUNE 25, 2007, A MEDWATCH UF/IMPORTER REPORT NUMBER 5201380000-2007-8007 WAS RECEIVED BY INTEGRA LIFESCIENCES CORPORATION. THE MEDWATCH REPORTED THE FOLLOWING INCIDENT: THE PATIENT DEVELOPED A POST-OPERATIVE INFECTION AFTER HAVING A SUBOCCIPITAL CRANIOTOMY FOR LESION RESECTION. THE PATIENT UNDERWENT LEFT RETROSIGMOID EXCISION OF AN ACOUSTIC NEUROMA. ONE MONTH LATER, THE PATIENT DEVELOPED WOUND DRAINAGE. TWO MONTHS AFTER THE DRAINAGE WAS DISCOVERED, IT INCREASED WHICH REQUIRED RE-ADMISSION TO THE HOSPITAL THE FOLLOWING MONTH (FOUR MONTHS AFTER THE INITIAL SURGERY). THE DEVICE WAS IMPLANTED IN 2006 AND EXPLANTED IN 2007. THE SAME YEAR, A MICROBIOLOGY OPERATIVE CULTURE REVEALED GRAM STAIN RARE PMNS. THE MEDWATCH FURTHER REPORTS THAT THE PATIENT HAD A HISTORY OF THYROIDECTOMY, STOMACH STAPLING, ANXIETY, DEPRESSION AND GERD. THE MEDWATCH ALSO REPORTS THE FOLLOWING DEVICES INVOLVED IN THE INCIDENT: BRAND: DUREPAIRE, MANUFACTURER: MEDTRONIC NEUROLOGICAL TECHNOLOGIES; CATALOG NUMBER: 62105; LOT NUMBER: 060837; IMPLANT DATE: 2007. EXPLANT DATE: 2007. BRAND: IMPACT BONE FILLER, BONE CEMENT; MANUFACTURER: OSTEOMED LP; CATALOG NUMBER: 39-2100. IMPLANT DATE: 2007; EXPLANT DATE: 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAGEN PLUS 3X3 SINGLE DURAGEN PLUS GXQ INTEGRA LIFESCIENCES 6041001

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention