BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DERMABOND UNKNOWN PRODUCT

    MDR report key: 7975600 · Received October 17, 2018

    Report

    Report Number
    2210968-2018-76615
    Event Type
    Injury
    Date Received
    October 17, 2018
    Report Date
    October 9, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    MPN
    PMA / PMN Number
    K100423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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: NEUROSURG FOCUS 31 (4):E15, 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: MANAGEMENT OF INCIDENTAL DUROTOMY IN MINIMALLY INVASIVE SPINE SURGERY" AUTHOR(S): DMITRY RUBAN, M.D., AND JOHN E. O¿TOOLE, M.D., M.S. CITATION: NEUROSURG FOCUS 31 (4):E15, 2011. THIS STUDY AIMED TO DESCRIBE THEIR EXPERIENCE IN A SERIES OF CONSECUTIVE MINIMALLY INVASIVE SPINE SURGERY (MISS). BETWEEN AUG2006 AND FEB2011, 563 PATIENTS UNDERWENT MISS AND 53 PATIENTS (N=23 MALE AND N=30 FEMALE; MEAN AGE OF 60.7 YEARS [RANGED 30-85 YEARS]) HAD UNINTENDED DUROTOMIES DURING THE PROCEDURE. IN THE REPAIR, PRIMARY REPAIR WAS PERFORMED USING 4-0 NUROLON SUTURES AND GELFOAM WAS USED IN DURAL DEFECT. 0 VICRYL WAS USED IN FASCIAL CLOSURE AND SKIN WAS CLOSED WITH INTERRUPTED 2-0 VICRYL SUBCUTANEOUS SUTURES FOLLOWED BY DERMABOND. COMPLICATIONS INCLUDED SUPERFICIAL WOUND INFECTION FOLLOWING A 1-LEVEL FUSION THAT REQUIRED A RETURN TO THE OPERATING ROOM FOR IRRIGATION AND DEBRIDEMENT, FOLLOWED SUCCESSFULLY BY A SHORT COURSE OF ANTIBIOTICS. UNINTENDED DUROTOMY WAS ASSOCIATED WITH FEWER COMPLICATIONS THAN PREVIOUSLY REPORTED FOR OPEN SPINAL SURGERY. THE AUTHORS PROPOSE A SIMPLE MANAGEMENT ALGORITHM THAT INCLUDES EARLY MOBILIZATION AND RESULTS IN EXCELLENT CLINICAL OUTCOMES WITH NO INCIDENCE OF POSTOPERATIVE CUTANEOUS CSF FISTULA OR OTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815261 DERMABOND UNKNOWN PRODUCT TOPICAL SKIN ADHESIVE MPN ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention