BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 9950313 · Received April 10, 2020

    Report

    Report Number
    2210968-2020-02935
    Event Type
    Injury
    Date Received
    April 10, 2020
    Report Date
    March 18, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: WORLD NEUROSURG. (2019) 123:390-401. / HTTPS://DOI.ORG/10.1016/J.WNEU.2018.11.135. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: SURGICAL PROTOCOL FOR INFECTIONS, NONHEALING WOUND PROPHYLAXIS, AND ANALGESIA: DEVELOPMENT AND IMPLEMENTATION FOR POSTERIOR SPINAL FUSIONS." AUTHOR(S): EVGENII BELYKH, ALESSANDRO CAROTENUTO, ANDREY A. KALININ, SERIK K. AKSHULAKOV, TALGAT KERIMBAYEV, VLADISLAV E. BORISOV, MARAT A. ALIYEV, PETER NAKAJI, MARK C. PREUL, VADIM A. BYVALTSEV. CITATION: WORLD NEUROSURG. (2019) 123:390-401. / HTTPS://DOI.ORG/10.1016/J.WNEU.2018.11.135. THE PURPOSE OF THIS PROSPECTIVE LONGITUDINAL CONTROLLED SINGLE-CENTER STUDY WAS TO ANALYZE THE EFFECTS OF A SURGICAL PROTOCOL FOR INFECTIONS, NONHEALING WOUND PROPHYLAXIS, AND ANALGESIA (SPINA) AMONG PATIENTS WHO UNDERWENT POSTERIOR SPINAL FUSION AT A SINGLE TERTIARY-CARE NEUROSURGICAL CENTER. IN 2015, A TOTAL OF 148 PATIENTS UNDERWENT DECOMPRESSION AND FUSION SURGERIES ON THE LUMBAR SPINE FOR VARIOUS DEGENERATIVE SPINE DISEASES. THE PATIENTS WERE DIVIDED INTO TWO: FIRST COHORT OF PATIENTS [CONTROL GROUP, (N=35 (N=30 FEMALE, N=5 MALE, MEDIAN AGE 45 YEARS (RANGE 31-54 YEARS), MEDIAN BMI 25.9 KG/M2))] WAS ENROLLED PROSPECTIVELY DURING A PERIOD OF 3 MONTHS; AND THE SECOND COHORT [STUDY GROUP, (N=113 (N=74 FEMALE, N=37 MALE, MEDIAN AGE 40 YEARS (RANGE 37-54 YEARS), MEDIAN BMI 27.8 KG/M2))] WAS ENROLLED DURING A 1-YEAR PERIOD AFTER THE IMPLEMENTATION OF THE SPINA. IN BOTH GROUPS, SURGICAL WOUND CLOSURE WAS STRICTLY PERFORMED IN LAYERS UNDER THE OPTICAL MAGNIFICATION OF THE OPERATIVE MICROSCOPE WITH USE OF ATRAUMATIC NEEDLE SUTURES. PARASPINAL MUSCLES WERE CLOSED WITH AN INTERRUPTED SUTURE WITHOUT OVERTIGHTENING THE LOOPS WITH USE OF 1-0 OR 2-0 ABSORBABLE SUTURES (VICRYL, ETHICON). THE DEEP FASCIA WAS CLOSED WITH INTERRUPTED SUTURES PLACED AT A 0.5-MM INTERVAL WITH USE OF 1-0 OR 2-0 SUTURES (VICRYL OR PDS II, ETHICON). SUBCUTANEOUS FAT WAS SUTURED IN 1 OR MORE LAYERS, DEPENDING ON THE THICKNESS, WITH INVERTED INTERRUPTED 3-0 SUTURES WITH PROLONGED RESORPTION TIME (E.G., VICRYL). THE DERMAL LAYER WAS CLOSED WITH AN OVERLAPPING CONTINUOUS SUTURE OR AN INTRADERMAL CONTINUOUS SUTURE WITH USE OF NONABSORBABLE 3-0 (PROLENE 3-0, ETHILON 3-0, ETHICON) OR ABSORBABLE 4-0 MONOFILAMENT (MONOCRYL 4-0, ETHICON) AND 4-0 PLUS DERMABOND (ETHICON) ON SKIN. POSTOPERATIVE COMPLICATIONS INCLUDED MINOR SURGICAL SITE INFECTIONS (SSIS) (N=23) WHICH WERE SUCCESSFULLY MANAGED WITH DRAINAGE OF THE SURGICAL WOUND AND ADMINISTRATION OF LOCAL ANTIBIOTIC OINTMENT, IN ADDITION TO ADMINISTRATION OF THE STANDARD POSTOPERATIVE SYSTEMIC ANTIBIOTICS; AND PAIN IN THE SURGICAL SITE (N=?) WHEREIN INJECTIONS OF NARCOTIC (TRAMADOL INTRAMUSCULAR 100 MG IN 2 ML) AND NONNARCOTIC ANALGESICS (KETOPROFEN INTRAMUSCULAR 100 MG IN 2 ML) WERE COMMONLY GIVEN. IMPLEMENTATION OF THE SURGICAL PROTOCOL FOR INFECTIONS, NONHEALING WOUND PROPHYLAXIS, AND ANALGESIA FOR POSTERIOR INTERVENTIONS ALLOWED US TO OPTIMIZE THE WOUND HEALING PROCESS, REDUCE THE RATE OF MINOR POSTOPERATIVE SSIS, AND SIGNIFICANTLY IMPROVE EARLY CLINICAL OUTCOMES. ESSENTIAL COMPONENTS OF THE PROTOCOL WERE CAREFUL MICROSURGICAL HEMOSTASIS, LAYERED WOUND CLOSURE WITH MODERN SUTURES, EFFECTIVELY CHOSEN PERIOPERATIVE ANTIBACTERIAL PROPHYLAXIS, AND LOCAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414336 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention