BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE TAPE UNKNOWN PRODUCT

    MDR report key: 13309978 · Received January 20, 2022

    Report

    Report Number
    2210968-2022-00548
    Event Type
    Injury
    Date Received
    January 20, 2022
    Date of Event
    January 14, 2020
    Report Date
    January 20, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4).IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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.

    Description of Event or Problem · 0

    TITLE: STRAP STABILIZATION FOR PROXIMAL JUNCTIONAL KYPHOSIS PREVENTION IN INSTRUMENTED POSTERIOR SPINAL FUSION THIS STUDY AIMS TO EVALUATE THE ASSOCIATION OF MERSILENE TAPE USE AND RISK OF PROXIMAL JUNCTIONAL KYPHOSIS (PJK), AFTER SURGICAL CORRECTION OF ADULT SPINAL DEFORMITY (ASD) BY POSTERIOR INSTRUMENTED FUSION (PIF). PATIENTS WHO UNDERWENT PIF FOR ASD WITH MERSILENE TAPE STABILIZATION (CASE GROUP) OR WITHOUT (CONTROL GROUP) BETWEEN 2006 AND 2016 WERE ANALYZED PREOPERATIVELY TO 2-YEAR FOLLOW-UP. EIGHTY PATIENTS WERE INCLUDED: (N=20 CASES AND N=60 CONTROLS). THE MEAN AGE WAS 62.3 YEARS OLD (SD 11.1) AND 63.8% WERE FEMALE. IN THE GROUP WHICH HAD BEEN INTERVENED WITH MERSILENE TAPE, THE CONSTRUCT WAS REINFORCED AT THE UIV AND ONE LEVEL ABOVE. THERE WAS NO DRILLING OF THE SPINOUS PROCESS. MERSILENE TAPE IS APPLIED AFTER POSTERIOR INSTRUMENTED FUSION (PIF). PROXIMALLY PASSED THROUGH THE SUPRA-ADJACENT LEVEL SPINOUS PROCESS. LOOPED IN A FIG. 8 WAY AROUND THE INFRA-ADJACENT SPINOUS PROCESS. PASSED UNDER THE RODS BILATERALLY, OR CROSS-LINK AND KNOTTED. MINIMAL PROXIMAL EXPOSURE IS NEEDED AS THE MERSILENE TAPE COMES ATTACHED TO A NEEDLE AND THE ADJACENT LEVEL SPINOUS PROCESS PROJECTS DOWNWARD, HENCE FACILITATING THE GRASP OF THE NEEDLE. REVISION/REOPERATION FOLLOWING THE INDEX OPERATION WAS NOT SIGNIFICANTLY DIFFERENT BETWEEN GROUPS AND OCCURRED IN 19 OF 80 PATIENTS (23.8%): N=4 CASES (20%) AND N=15 CONTROLS (25%). THE MEAN IMMEDIATE POSTOPERATIVE CHANGES WERE DIFFERENT: DECREASED IN THE CASE GROUP (- 1.8°) AND INCREASED IN THE CONTROL GROUP (0.7°), P = 0.01. THE TOTAL CUMULATIVE RATE OF PJK/PJF IN THE WHOLE STUDIED POPULATION AT 2-YEAR FOLLOW-UP WAS 26/80 (32.5%): N=3 OF 20 (15%) WITH MERSILENE TAPE AND N=23 OF 60 (38.37%) WITHOUT. THE RISK OF PJK/PJF WAS MORE THAN TWO TIMES LESS IN THE CASE GROUP: OR = 0.28 (95% CL: 0.07; 1.1), ¿2 = 4.8; P = 0.045. THE CUMULATIVE RATE OF PJK = 10° AT 2-YEAR FOLLOW-UP WAS 15% IN CASES VERSUS 38% OF CONTROLS (OR = 0.28; P = 0.04) WITH HIGHER LATENT PERIOD IN CASES, (20 VS. 7.5 MONTHS), P = 0.018. MERSILENE TAPE DECREASED RISK OF PJK LINKED WITH THE IMPACT OF THE FOLLOWING CONFOUNDERS: AGE, = 55 YEARS OLD (OR = 0.19; 0.02 = P = 0.03); NUMBER OF SPINAL LEVELS FUSED 7¿15 (OR = 0.13; 0.02 = P = 0.06); THORACIC UIV (T12¿T1) (OR = 0.13; 0.02 = P = 0.06); BMI = 27 KG/M2 (OR = 0.22; 0.03 = P = 0.08); AND OSTEOPOROSIS (OR = 0.13; 0.02 = P = 0.08) . REPORTED COMPLICATIONS IN THE CASE GROUP INCLUDED N=3 PJK/PJF (PROXIMAL JUNCTIONAL KYPHOSIS/ PROXIMAL JUNCTIONAL FAILURE) , N=2 VERTEBRAL FRACTURE, N=1 PSEUDOARTHROSIS AND N=4 POSTOPERATIVE REVISION/ REOPERATION. IN CONCLUSION, MERSILENE TAPE STABILIZATION OF THE SPINE AT UIV + 1 DECREASES THE RISK OF PJK AFTER CORRECTION OF ASD BY LONG PIF. THIS PROTECTIVE EFFECT IS EXPECTED WITHIN 2 YEARS POSTOPERATIVELY, ESPECIALLY IN PATIENTS WITH: INCREASED AGE, OBESITY, OSTEOPOROSIS, CONSTRUCTS = SEVEN LEVELS, AND THORACIC UIV. THIS IS AN EARLY PILOT STUDY PROPOSING MERSILENE TAPE STABILIZATION FOR PJK PREVENTION IN = THREE-LEVEL PIF CONSTRUCTS AND HIGHLIGHTS PATIENT CHARACTERISTICS THAT CONFER THE GREATEST BENEFIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69005 MERSILENE TAPE UNKNOWN PRODUCT SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention