BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUROLON NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 7984850 · Received October 19, 2018

    Report

    Report Number
    2210968-2018-76654
    Event Type
    Injury
    Date Received
    October 19, 2018
    Report Date
    October 4, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE 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 PRODUCT (NUROLON 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 PRODUCT INVOLVED? CITATION: ACTA NEUROCHIR. 2015; 157: 507¿511. DOI: 10.1007/S00701-014-2263-X. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "ALLODERM FOR DURAPLASTY IN CHIARI MALFORMATION: SUPERIOR OUTCOMES." AUTHORS: CHRISTIAN A. BOWERS & CAMERON BRIMLEY & CHAD COLE & WAYNE GLUF & RICHARD H. SCHMIDT. CITATION: ACTA NEUROCHIR. 2015; 157: 507¿511. DOI: 10.1007/S00701-014-2263-X . THE AUTHORS REVIEWED THEIR EXPERIENCE TO COMPARE THE INCIDENCE OF GRAFT-RELATED COMPLICATIONS ASSOCIATED WITH USING ACELLULAR HUMAN DERMIS ALLOGRAFT (ALLODERM) WITH THOSE OF DURAGUARD, DURAGEN, AND DUREPAIR. A TOTAL OF 119 PATIENTS (96 FEMALE AND 23 MALE PATIENTS; AGE: 33.98 ± 11.6; BMI: 28.98 ± 6.80) UNDERWENT 128 CHIARI DECOMPRESSION PROCEDURES FROM JANUARY 1, 1997 THROUGH JULY 31, 2012. IN ALL PATIENTS, DURAL SUTURING WAS DONE IN A RUNNING FASHION ON EACH SIDE WITH NON-ABSORBABLE NEUROLON 4-0 SUTURES (ETHICON) AND WATERLIGHT DURAL CLOSURE WAS TESTED WITH A VALSALVA MANEUVER. IN ALL PATIENTS, REPORTED COMPLICATION INCLUDED GRAFT FAILURE LEADING TO PSEUDOMENINGOCELE OCCURRENCE (N-15; ALLODERM: N-1; NON-ALLODERM: N-14) WHICH REQUIRED RE-OPERATION, ASEPTIC MENINGITIS (N-3) WHICH NECESSITATES WORK-UP WITH CSF ANALYSIS BY LUMBAR PUNCTURE AND TREATMENT WITH CORTICOSTEROIDS, AND DURAL GRAFT LEAK (N-3) WHICH REQUIRED RESCUE DURAPLASTY. THE USE OF THE ALLODERM DURAL GRAFT FOR DURAPLASTY IN CHIARI DECOMPRESSIONS RESULTED IN A SIGNIFICANTLY LOWER PSEUDOMENINGOCELE FORMATION THAN THE USE OF ANY OTHER TYPE OF DURAL GRAFT. THERE WAS NO ASSOCIATION BETWEEN PATIENT AGE, SEX, EXTRA WEIGHT, OR SMOKING STATUS AND THE NEED FOR RE-OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824409 NUROLON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NON ABSORBABLE, SYNTHETIC, POLYAMIDE GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DURAL GRAFT