BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAFORM

    MDR report key: 5926081 · Received September 2, 2016

    Report

    Report Number
    1226348-2016-10623
    Event Type
    Injury
    Date Received
    September 2, 2016
    Date of Event
    August 7, 2014
    Product Code
    GXQ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿HEALTH CARE COSTS OF INCIDENTAL DUROTOMIES AND POSTOPERATIVE CEREBROSPINAL FLUID LEAKS AFTER ELECTIVE SPINAL SURGERY¿ PUBLISHED EUR SPINE J (2015) 24:2065¿2068, DOI 10.1007/S00586-014-3504-7, IT WAS REPORTED THAT ON PATIENT HAD CSF LEAKAGE POST DURAFORM IMPLANTATION. PER THE ARTICLE: ¿TO EXPLORE THE ADDITIONAL HEALTH CARE COSTS OF INCIDENTAL DUROTOMIES AND CEREBROSPINAL FLUID (CSF) LEAKS AFTER ELECTIVE SURGERY FOR DEGENERATIVE SPINAL DISORDERS¿ INCIDENTAL DUROTOMY OR POSTOPERATIVE CEREBROSPINAL FLUID LEAK AFTER ELECTIVE SURGERY FOR DEGENERATIVE SPINAL DISORDERS CAUSES SIGNIFICANTLY HIGHER HEALTH CARE COSTS.¿ AGAIN PER THE ARTICLE¿ ONLY ONE OF 10 PATIENTS WITH AN INTRAOPERATIVE DURAL TEAR DEVELOPED A POSTOPERATIVE CSF LEAK, THIS PATIENT WAS A (B)(6) LADY OPERATED WITH MICROSURGICAL DECOMPRESSION AND IMPLANTATION OF AN INTERSPINOUS DEVICE FOR LUMBAR SPINAL STENOSIS. A PRIMARY SUTURE OF THE DURAL DEFECT WAS INITIALLY NOT PERFORMED BECAUSE OF THE LATERAL LOCALIZATION OF THE DUROTOMY, BUT THE DEFECT WAS COVERED WITH AN ARTIFICIAL DURAL GRAFT IMPLANT (DURAFORMTM, (B)(4)) AND SEALED WITH A SYNTHETIC POLYMER GLUE NON-CODMAN. THE PATIENT DEVELOPED SPINAL HEADACHE 8 DAYS AFTER SURGERY; IN ADDITION, A SUBCUTANEOUS FLUID COLLECTION OCCURRED IN RELATION TO THE SITE OF SURGERY. MR IMAGING VERIFIED A FLUID COLLECTION LOCATED TO THE SURGICAL APPROACH CONSISTENT WITH A POSTOPERATIVE CSF LEAK. REVISION SURGERY WAS PERFORMED, THE APPROACH TO THE SPINAL CANAL WAS ENLARGED, THE DURAL DEFECT WAS EXPOSED AND SUTURED AND THE DEFECT WAS AGAIN COVERED WITH DURAFORMTM ((B)(4)) AND A NON-CODMAN DEVICE. THE PATIENT WAS CONFINED TO BED FOR 3 DAYS AND STAYED IN HOSPITAL FOR IN TOTAL 22 DAYS AFTER PRIMARY SURGERY. NO RECURRENCE OF THE CSF LEAK OCCURRED AND THE FINAL CLINICAL OUTCOME WAS FAVORABLE. AT THE TIME OF COMPLAINT ENTRY NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575933 DURAFORM DURA SUBSTITUTE GXQ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention