BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUROLON NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 8025872 · Received October 31, 2018

    Report

    Report Number
    2210968-2018-76860
    Event Type
    Injury
    Date Received
    October 31, 2018
    Report Date
    October 16, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: NEUROSURGERY. 2012; 71 (2): 302¿307. DOI: 10.1227/NEU.0B013E31826A8AB0. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: "AUGMENTED AUTOLOGOUS PERICRANIUM DURAPLASTY IN 100 POSTERIOR FOSSA SURGERIES¿A RETROSPECTIVE CASE SERIES," AUTHORS: FRED C. LAM, MD, PHD, EKKEHARD KASPER, MD, PHD. CITATION: NEUROSURGERY. 2012; 71 (2): 302¿307. DOI: 10.1227/NEU.0B013E31826A8AB0. THE OBJECTIVES OF THE STUDY WAS TO REPORT OUR EXPERIENCE USING LOCALLY HARVESTED AUTOLOGOUS PERICRANIUM AS A DURAL SUBSTITUTE IN PATIENTS WHO UNDERWENT P-FOSSA SURGERIES. THIS IS A RETROSPECTIVE ANALYSIS OF 100 PATIENTS (43 MALE AND 57 FEMALE PATIENTS; AGE RANGE: 22 TO 94 YEARS OLD) WHO HAD UNDERGONE P-FOSSA CRANIOTOMIES BETWEEN 2005 AND 2011. DURING THE SURGICAL PROCEDURE, FOLLOWING THE BONY DECOMPRESSION AND DUROTOMY, THE PERICRANIUM IS SHAPED TO THE DURAL DEFECT AND SUTURED IN BY THE USE OF NUROLON 4-0 RUNNING BRAIDED SILK (ETHICON), APPLIED METICULOUSLY UNDER THE OPERATING MICROSCOPE OR LOUPES MAGNIFICATION. THIS PATCH IS THEN PATTED DRY BY A SPONGE AND COVERED WITH 1 LAYER OF SURGICEL (ETHICON) WHICH IS SPRAY COVERED WITH DURAL SEALANT OR EVECIL (ETHICON) TO AUGMENT THE WATERTIGHT CLOSURE. EACH CLOSURE WAS TESTED INTRAOPERATIVELY PRE AND POST SEALANT APPLICATION WITH A VALSALVA MANEUVER. IF NO FLUID LEAK WAS OBSERVED, THE CASE WAS CLOSED IN A ROUTINE FASHION BY APPLYING A LAYER OF THROMBIN-SOAKED SURGIFOAM (ETHICON) WITH OR WITHOUT SUBSEQUENT CRANIOPLASTY, FINALLY FOLLOWED BY A MULTILAYER CLOSURE OF THE SOFT TISSUES. REPORTED COMPLICATION INCLUDED DEHISCENCE IN THE CENTER OF THE GRAFT (N-1) WHICH REQUIRED SURGICAL REPAIR. AUTOLOGOUS PERICRANIUM WITH DURAL SEALANT AUGMENTATION IS AN EFFECTIVE WAY TO REPAIR THE DUROTOMY IN P-FOSSA SURGERIES. THIS IS CURRENTLY THE LARGEST STUDY USING THIS TECHNIQUE IN THE ADULT NEUROSURGICAL LITERATURE. THE RESULTS REPORTED A MUCH LOWER RATE OF COMPLICATIONS IN COMPARISON WITH OTHER DURAPLASTY STUDIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863352 NUROLON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NON ABSORBABLE, SYNTHETIC, POLYAMIDE GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SURGICEL, EVICEL, SURGIFOAM