BEUDAMED
    FDA Adverse Event Other Summary report: N

    BG3505-5-US BIOGLUE ADHESIVE 5ML SYRINGE (5 PACK)

    MDR report key: 634605 · Received September 13, 2005

    Report

    Report Number
    1063481-2005-00026
    Event Type
    Other
    Date Received
    September 13, 2005
    Date of Event
    July 4, 2005
    Report Date
    August 15, 2005
    Manufacturer
    CRYOLIFE, INC.
    Product Code
    MFI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED WITH SEVERE SPINAL STENOSIS @ L4 -L5. PATIENT UNDERWENT HEMILAMINACTOMY WITH MEDIAL FACETECTOMY AND DISECTOMY ON RIGHT SIDE DURA ADHERENT TO LIGANEMTUM FLAVUN. SURGEON ALSO ADDRESSED LEFT SIDE LAMINOTOMY, DURA AGAIN ADHERENT TO LIGAMENTUM FLAVUM. SURGEON INSERTED KERRISON PUNCH TO REMOVE PORTION OF LIGAMENT. WHEN PUNCH WAS REMOVED, THE SURGEON NOTICED A LARGE CSF LEAK. HE THEN USED GELFOAM THEN BLUEGLUE TO TAMPONADE (NOT AN INDICATED USE FOR BIOGLUE IN THE UNITED STATES) WHICH DID NOT STOP LEAKAGE. SURGEON USED MUSCLE FLAP AND MORE BIOGLUE WHICH APPEARED TO STOP CSF LEAKAGE, HOWEVER, HE THEN NOTICED CSF COMING FROM OTHER (R) SIDE, AND INSERTED "1CM BY SEVERAL MM" BG TO STOP LEAK IN O.R. SYX OF CSF LEAK POSTOP - RX 3 DAYS BED REST - PT WAS ASYX, BUT IMMEDIATELY SYX AGAIN UPON RISING. RX 7 DAYS LUMBAR DRAINAGE - PT. D/C HOME W/ NO CSF LEAK. PATIENT BEGAN EXPERIENCING TRANSIENT LEG PAIN (SCIATICA - TYPE ). GRADUALLY IMPROVED BUT WORSENED ON 08/2005. MRI & CT AT THAT TIME SHOWED COMPRESSION LESION ON RIGHT SIDE AT L4-L5. PAIN SUBSIDED, PATIENT "SWAM IN FRIENDS POOL FOR 2 HOURS. AND PAIN RETURNED NEXT DAY. SURGEON EXAMINED PATIENT AND NOTED PATIENT WAS "NEUROLOGICALLY INTACT." PATIENT IS ALSO NEGATIVE FOR INFECTION SURGEON IS PLANNING PO STEROIDS (DECADRON) AND WILL CALL THE REP BACK IF HE3 DECIDES TO RE-OPERATE; HOWEVER, AS OF 09/2005, SURGEON INDICATED THAT PATIENT WAS "DOING WELL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BG3505-5-US BIOGLUE ADHESIVE 5ML SYRINGE (5 PACK) BIOGLUE SURGICAL ADHESIVE MFI CRYOLIFE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other