BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 12566165 · Received October 1, 2021

    Report

    Report Number
    2210968-2021-09106
    Event Type
    Injury
    Date Received
    October 1, 2021
    Date of Event
    October 20, 2020
    Report Date
    September 16, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS, DEMOGRAPHICS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE AUTHOR/ SURGEON BELIEVE THAT ETHICON PRODUCTS (VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO POST-OP COMPLICATIONS (DELAYED POSTOPERATIVE (>90 DAYS): POSTOPERATIVE FEVER AND SEPSIS) DESCRIBED IN THE ARTICLE? PLEASE SPECIFY. DOES THE AUTHOR/ SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (VICRYL SUTURE) USED IN THESE CASES DESCRIBED IN THIS STUDY? IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS (DELAYED POSTOPERATIVE (>90 DAYS): POSTOPERATIVE FEVER AND SEPSIS)? WERE ALL THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION:THE SPINE JOURNAL 21 (2021) 418-429, HTTPS://DOI.ORG/10.1016/J.SPINEE.2020.10.016.

    Description of Event or Problem · 1

    TITLE: INCLUSION OF L5-S1 IN OBLIQUE LUMBAR INTERBODY FUSION-TECHNIQUES AND EARLY COMPLICATIONS-A SINGLE CENTER EXPERIENCE. THIS RETROSPECTIVE STUDY AIMS TO EVALUATE OUR EARLY EXPERIENCE WITH THE SAFETY OF INCLUDING L5-S1 IN OBLIQUE LUMBAR INTERBODY FUSION (OLIF) USING 3 DIFFERENT TECHNIQUES, AS WELL AS TO COMPARE THE EARLY COMPLICATIONS AND MORBIDITY BETWEEN OBLIQUE LUMBAR INTERBODY FUSION (OLIF) WITH AND WITHOUT L5-S1 INCLUSION. BETWEEN DECEMBER 2016 AND NOVEMBER 2019, THE MEDICAL RECORDS AND IMAGING DATA OF 87 CONSECUTIVE PATIENTS (82 MALES, 5 FEMALES) AGE (B)(6) (43-76 YEARS) WHO UNDERWENT OLIF FOR SYMPTOMATIC DEGENERATIVE LUMBAR PATHOLOGY WERE REVIEWED. PATIENTS WERE DIVIDED INTO TWO GROUPS: THOSE WHO UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION (OLIF) AT LEVELS INCLUDING L5-S1 (GROUP A) WITH 19 PATIENTS (18 MALES AND 1 FEMALE) AGE (B)(6) YEARS AND THOSE WITHOUT INCLUSION OF L5-S1 (GROUP B) WITH 68 PATIENTS (64 MALES AND 4 FEMALES) AGE (B)(6) YEARS. DURING SURGERY, A CAREFUL BLUNT DISSECTION TO IDENTIFY AND LIGATE THE LEFT ILIOLUMBAR VEIN (ILV), IF PRESENT, AND ANTEROMEDIAL MOBILIZATION OF THE LEFT COMMON ILIAC VEIN (CIV) WAS INVOLVED. LIGATION OF THE ILIOLUMBAR VEIN (ILV), SEGMENTAL VEINS, MEDIAN SACRAL VESSELS, OR ANY VASCULAR STRUCTURE AS NEEDED FOR ADEQUATE EXPOSURE WAS REQUIRED IN 13 PATIENTS FROM GROUP A AND 4 FROM GROUP B; VESSELS THAT WERE SMALL ENOUGH TO BE COAGULATED VIA BIPOLAR CAUTERY WERE NOT INCLUDED IN THIS COUNT. SILK OR VICRYL (ETHICON) SUTURES OR VASCULAR CLIPS WERE USED FOR LIGATION (SURGEON¿S CHOICE). THE AVERAGE FOLLOW-UP WAS 10.8 (RANGE, 6 -36) MONTHS AND INDICATIONS FOR SURGERY WERE SIMILAR BETWEEN THE GROUPS. REPORTED COMPLICATIONS INCLUDED: DELAYED POSTOPERATIVE (>90 DAYS): POSTOPERATIVE FEVER (N=1) AND SEPSIS (N= 2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1460593 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1