BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT

    MDR report key: 9841775 · Received March 17, 2020

    Report

    Report Number
    2210968-2020-02141
    Event Type
    Injury
    Date Received
    March 17, 2020
    Report Date
    February 21, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (MERSILENE SUTURE, ETHILON SUTURE) 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 (MERSILENE SUTURE, ETHILON SUTURE) USED IN THIS PROCEDURE? WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON RECOLLECT THE TOTAL NUMBER OF PATIENTS WHO HAD PERSISTENT CSF LEAKAGE AND UTILIZED ETHICON SUTURE DURING THE PROCEDURE? PATIENT DEMOGRAPHICS. CITATION: EUROPEAN SPINE JOURNAL (2020) 29:141¿146; HTTPS://DOI.ORG/10.1007/S00586-019-06144-5. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: NO BENEFIT OF EARLY VERSUS LATE AMBULATION AFTER INCIDENTAL DUROTOMY IN LUMBAR SPINE SURGERY: A RANDOMIZED CONTROLLED TRIAL" AUTHOR: MAZDA FARSHAD, ALEXANDER AICHMAIR, FLORIAN WANIVENHAUS, MICHAEL BETZ, JOSE SPIRIG, DAVID EPHRAIM BAUER. CITATION: EUROPEAN SPINE JOURNAL (2020) 29:141¿146; HTTPS://DOI.ORG/10.1007/S00586-019-06144-5. THE AIM OF THIS RANDOMIZED CONTROLLED STUDY WAS TO INVESTIGATE THE RATE OF CSF LEAKAGE AND REQUIRED SURGICAL REVISIONS, AS WELL AS MEDICAL COMPLICATIONS AND DURATION OF HOSPITALIZATION, WITH EARLY VERSUS LATE POST-OPERATIVE AMBULATION AFTER REPAIRED INCIDENTAL DUROTOMY (ID) DURING DECOMPRESSIVE SPINAL SURGERY. BETWEEN OCTOBER 2015 AND JANUARY 2018, A TOTAL OF 30 PATIENTS (N=11 MALES AND N=19 FEMALES, MEAN AGE: 65 YEARS) WERE RANDOMIZED INTO THE PROLONGED FLAT BED REST GROUP (BR GROUP) AND 30 PATIENTS (N=18 MALES, N=12 FEMALES, MEAN AGE 63 YEARS) INTO THE EARLY POST-OPERATIVE AMBULATION GROUP (EA GROUP). CLOSING OF THE DURAL INJURY WAS PERFORMED ACCORDING TO INSTITUTIONAL STANDARDS WITH RUNNING STITCHES USING NONABSORBABLE SUTURES (MERSILENE) (ETHICON) AND A FIBRIN SEALANT PATCH (TACHOSIL), A FIBRIN SEALANT PATCH ALONE, SUTURE REPAIR AND HYDROGEL (DURASEAL) OR HYDROGEL ALONE AT THE DISCRETION OF THE SURGEON AFTER CONSIDERATION OF THE MORPHOLOGY AND LOCATION OF THE DURAL TEAR. MUSCULAR FACIAL AND SKIN CLOSURE WAS ACHIEVED WITH ETHIBOND AND ETHILON NONABSORBABLE SUTURES (ETHICON), RESPECTIVELY. COMPLAINT INCLUDED PERSISTING SYMPTOMS OF CSF LEAKAGE (N=2 IN THE BR GROUP AND N=2 IN THE EA GROUP) WHICH REQUIRED REVISION SURGERY, SUPERFICIAL WOUND COMPLICATION (N=2 IN THE BR GROUP AND N=1 IN THE EA GROUP). THE RESULTS OF THIS STUDY INDICATE NO BENEFIT OF PROLONGED BED REST AFTER AN ADEQUATELY REPAIRED ID IN LUMBAR SPINE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305386 MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention