BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 13309628 · Received January 20, 2022

    Report

    Report Number
    2210968-2022-00547
    Event Type
    Injury
    Date Received
    January 20, 2022
    Date of Event
    September 13, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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. DOES THE SURGEON BELIEVE THAT ANY OF THE 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 ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? WHAT SURGICAL OR MEDICAL INTERVENTION HAS BEEN PERFORMED? 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2022-00545 AND 2210968-2022-00547. CITATION: ERIC O. KLINEBERG HTTPS://ORCID.ORG/0000-0003-1408-106X.

    Description of Event or Problem · 0

    TITLE: LIGAMENT AUGMENTATION WITH MERSILENE TAPE REDUCES THE RATES OF PROXIMAL JUNCTIONAL KYPHOSIS AND FAILURE IN ADULT SPINAL DEFORMITY. THE OBJECTIVES OF THIS STUDY WAS INVESTIGATE PREVENTION OF PROXIMAL JUNCTIONAL KYPHOSIS (PJK) AND FAILURE (PJF) FOLLOWING ADULT SPINAL DEFORMITY (ASD) SURGERY UTILIZING A NOVEL TECHNIQUE OF POSTERIOR LIGAMENT AUGMENTATION WITH POLYESTER FIBER TETHER. THIS STUDY EVALUATED ADULT SPINAL DEFORMITY (ASD) ADULT PATIENTS WHO UNDERWENT POSTERIOR DECOMPRESSION AND INSTRUMENTED FUSION FROM THE THORACOLUMBAR JUNCTION (T9¿L1) TO THE PELVIS FROM 2011¿2017. A TOTAL OF 43 SUBJECTS WERE EVALUATED, INCLUDING 20 WITHOUT AND 23 WITH LIGAMENTOUS AUGMENTATION. PATIENTS WHO UNDERWENT SURGERY BETWEEN 2011 AND 2015 WERE PART OF THE NONAUGMENTED GROUP WHEREAS PATIENTS WHO UNDERWENT SURGERY BETWEEN 2016 AND 2017 WERE PART OF THE AUGMENTED GROUP. MERSILENE TAPE ETHICON WAS USED. REPORTED COMPLICATIONS INCLUDED REVISION SURGERY WITHIN 2 YEARS OF SURGERY (N=7), FRACTURE (N=8), SYMPTOMATIC PROXIMAL JUNCTIONAL KYPHOSIS (N=1), HOOK PULL-OUT (N=7). IN CONCLUSION NOVEL LIGAMENT AUGMENTATION TECHNIQUE UTILIZING POLYETHYLENE TAPE IS AN EFFECTIVE TECHNIQUE TO SLOW PROGRESSION OF THE PJA AND LOWER THE RISK FOR PROXIMAL JUNCTIONAL DISEASE IN ASD SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92890 MERSILENE TAPE UNKNOWN PRODUCT SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention