BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 8470215 · Received April 1, 2019

    Report

    Report Number
    2210968-2019-79839
    Event Type
    Injury
    Date Received
    April 1, 2019
    Report Date
    March 5, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    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 PRODUCTS (NYLON, VICRYL, VICRYL PLUS SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHAT IS THE SPECIFIC "MINOR COMPLICATION" REPORTED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (NYLON, VICRYL, VICRYL PLUS SUTURE) USED IN THIS PROCEDURE? CITATION: REV FAC ODONTOL UNIV ANTIOQ 2017; 28 (2): 235-260. DOI: 10.17533/UDEA.RFO.V28N2A1. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: MAXILLARY SINUS FLOOR LIFTING USING FREEZE-DRIED HOMOLOGOUS BONE AND TIBIA AUTOLOGOUS BONE: REPORT ON RADIOGRAPHIC AND HISTOLOGICAL RESULTS," AUTHORS: JOSE S. DOMINGUEZ MEJIA, OMAR ALBERTO RAMIREZ USUGA, YONNY ALEJANDRO BLANDON LOPEZ, CITATION: REV FAC ODONTOL UNIV ANTIOQ 2017; 28 (2): 235-260. DOI: 10.17533/UDEA.RFO.V28N2A1. AUTOLOGOUS BONE GRAFTS FOR MAXILLARY SINUS FLOOR LIFTING ARE WIDELY ACCEPTED TO RECONSTRUCT ALVEOLAR RIDGE DEFECTS; HOWEVER, THERE ARE DONOR SITES THAT HAVE NOT BEEN FULLY EXPLORED AND CAN BE VALID ALTERNATIVES FOR THIS TYPE OF PROCEDURES. THE OBJECTIVE OF THIS STUDY IS TO COMPARE THE RADIOGRAPHIC AND HISTOLOGICAL BEHAVIOR OF AUTOLOGOUS BONE EXTRACTED FROM TIBIA AND DEMINERALIZED FREEZE-DRIED HOMOLOGOUS BONE IN THE LIFTING OF MAXILLARY SINUS. BETWEEN JUNE 2007 AND DECEMBER 2009, A TOTAL OF 19 OPERATED MAXILLARY SINUSES FROM 16 PATIENTS (MALE 5 AND FEMALE 11; AGE RANGES FROM: 23-66 YEARS OLD) WERE SURGICALLY INTERVENED IN A RANDOM MANNER TO PERFORM MAXILLARY SINUS ELEVATION BEFORE PLACING IMPLANTS IN THE POSTERIOR MAXILLARY REGION. TEN MAXILLARY SINUSES PROCEDURE WAS DONE USING FREEZE-DRIED HOMOLOGOUS BONE AS GRAFT MATERIAL (GROUP 1) AND NINE AUTOLOGOUS BONE EXTRACTED FROM PROXIMAL TIBIA WAS USED AS GRAFT (GROUP 2). DURING EXTRACTION OF THE TIBIA GRAFT, THE WOUND WAS CLOSED BY PLANES WITH VICRYL 3-0 (ETHICON) IN THE DEEP PART AND 6-0 NYLON (ETHICON) IN THE SKIN, AND THIS WAS SUBDERMAL TO ACHIEVE A MORE AESTHETIC APPEARANCE OF THE FINAL SCAR. DURING SINUS LIFT, THE SURGICAL WOUND WAS CLOSED USING VICRYL PLUS 4-0 SUTURE (ETHICON) BY MEANS OF SIMPLE POINTS IN BOTH THE VERTICAL INCISIONS AND THE CRESTAL AREA. REPORTED COMPLICATIONS INCLUDED SURGICAL WOUND INFECTION (N-1) WHICH WAS MANAGED WITH ANTIBIOTIC THERAPY WITH DICLOXACILLIN AND WAS RESOLVED WITH NO FURTHER COMPLICATIONS, AND MINOR COMPLICATION (N-1). IN CONCLUSION, TIBIA BONE SHOWS GREATER STABILITY IN THE EVALUATED PERIOD IN TERMS OF THE HEIGHT OBTAINED IN MAXILLARY SINUS FLOOR LIFTING PROCEDURES, WITH CLINICAL AND HISTOLOGICAL CHARACTERISTICS SUITABLE FOR THE PLACEMENT OF IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263651 NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention