BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASEAL PRODUCT

    MDR report key: 2427718 · Received January 18, 2012

    Report

    Report Number
    1219930-2012-00043
    Event Type
    Injury
    Date Received
    January 18, 2012
    Date of Event
    December 11, 2011
    Report Date
    December 16, 2011
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    NQR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: PT RETURNED TO THE HOSPITAL ON (B)(6) 2011 WITH NEUROLOGICAL DEFICITS AND AN MRI REVEALED A COLLECTION CAUSING COMPRESSION. RE-OPERATION WAS PERFORMED AND REVEALED THAT THE PRODUCT HAD SWELLED COMBINED WITH AND A DISC FRAGMENT, WHICH WAS CAUSING THE L4-L5 NERVE ROOT COMPRESSION. ONE DAY POST-OPERATIVELY, PATIENT SYMPTOMS HAVE IMPROVED. ON (B)(6) 2011, THE PT WAS RE-ADMITTED TO THE HOSPITAL AFTER A FALL. AN MRI REVEALED SPINAL CORD COMPRESSION AT L4-L5 AND A 2ND RE-OPERATION WAS PERFORMED ON (B)(6) 2011 FOR A SPINAL CORD DECOMPRESSION. DURING THE PROCEDURE, THERE WAS A YELLOW FLUID NOTED TO BE PRESENT ALONG WITH SOME SCAR TISSUE WHICH WAS REMOVED. SEVERAL VALSALVA MEASURES WERE PERFORMED, HOWEVER, NO CEREBROSPINAL FLUID WAS OBSERVED. FLUID CULTURES ARE STILL PENDING. FURTHER INFO WILL BE PROVIDED ONCE IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURASEAL PRODUCT DURASEAL EXACT SPINE SEALANT NQR UNITED STATES SURGICAL N2K0441WX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R