BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS PLATE UNKNOWN PRODUCT

    MDR report key: 9348550 · Received November 20, 2019

    Report

    Report Number
    2210968-2019-90132
    Event Type
    Injury
    Date Received
    November 20, 2019
    Report Date
    October 30, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    NHB
    PMA / PMN Number
    K092590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT IS THE PHYSICIAN¿S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? POSSIBLY INFECTION. HOW WAS THE ABOVE PATIENT TREATED (ANTIBIOTICS/RE-SURGERY/OTHER, EXPLAIN)? ANTIBIOTICS, CLEANING IN CLINICS, NO SURGICAL INTERVENTION. PATIENT¿S CURRENT CONDITION? UNKNOWN. REPERFORATED SEPTUM. IDENTICAL TO PREOP. 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. CITATION: AM J RHINOL ALLERGY (2017); 31:190-195. DOI: 10.2500/AJRA.2017.31.4431. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: CLOSURE OF NASAL SEPTAL PERFORATIONS WITH A POLYDIOXANONE PLATE AND TEMPOROPARIETAL FASCIA IN A CLOSED APPROACH" AUTHORS: LORENZ EPPRECHT, M.D., CHRISTOPH SCHLEGEL, M.D., DAVID HOLZMANN, M.D., MICHAEL SOYKA, M.D., AND THOMAS KAUFMANN, M.D. CITATION: AM J RHINOL ALLERGY (2017); 31:190-195. DOI: 10.2500/AJRA.2017.31.4431. THE AIM OF THIS STUDY IS TO PROVIDE THE FIRST RESULTS OF A CASE SERIES OF 20 PATIENTS (7 MALE AND 13 FEMALE; MEAN AGE 33 YEARS; AGE RANGE: 15-57 YEARS) WITH NASAL SEPTAL PERFORATIONS WHO UNDERWENT SEPTAL PERFORATION REPAIR BY BOTH AN OPEN AND A MINIMALLY INVASIVE TECHNIQUE BY USING A GRAFT THAT CONSISTED OF TEMPOROPARIETAL FASCIA AND A POLYDIOXANONE (PDS) PLATE WITHOUT MUCOSAL FLAPS. BETWEEN 2014 AND 2016, 7 PATIENTS (35%) HAD SURGERY VIA A COLUMELLAR INCISION AND 13 (65%) BY A MODIFIED TECHNIQUE. ONE LAYER OF TEMPOROPARIETAL FASCIA (TPF) WAS HARVESTED THROUGH A 3¿4¿CM SUPRAAURICULAR AND CORONAL INCISION IN THE SCALP. TPF WAS HARVESTED, DEPENDING ON THE PERFORATION SIZE, TO COMPLETELY ENVELOP A 0.25-MM PDS FLEXIBLE PLATE (ETHICON). THE TPF WAS DOUBLE THE SIZE OF THE PDS PLATE. THE PDS PLATE WAS PREVIOUSLY FITTED TO THE PERFORATION SIZE. THE SIZE OF THE PLATE WAS DESIGNED TO OVERLAP THE PERFORATION BY 5 MM ON ALL SIDES. THE SIDE OF THE FASCIA THAT LAID ON THE TEMPORAL MUSCLE BEFORE BEING HARVESTED WAS FOLDED TO THE INSIDE OF THE GRAFT THAT FACED THE PDS PLATE. THE APPROACH FOR THE INSERTION OF THE GRAFT WAS THEN PERFORMED EITHER BY A COLUMELLAR, ¿INVERTED V,¿ CUT (OPEN PROCEDURE), OR BY A HEMITRANSFIXION (CLOSED PROCEDURE) INCISION. THE OPEN PROCEDURE WAS ONLY USED IN LARGE PERFORATIONS WHERE THE GRAFT DID NOT FIT THROUGH A HEMITRANSFIXION INCISION. THE NASAL SEPTAL MUCOSA WAS DETACHED FROM THE CARTILAGE ON BOTH SIDES OF THE SEPTUM. SUBSEQUENTLY, THE GRAFT WAS INSERTED INTO THE PERFORATION. REPORTED COMPLICATION INCLUDED DISLOCATION OF THE GRAFT (N-1) AND IN PATIENT 020, A (B)(6)-YEAR OLD FEMALE PATIENT WITH REPERFORATION DUE TO A LOCAL INFECTION, IMMEDIATELY AFTER SURGERY. THE STUDY SHOWED THAT THE INSERTION OF A GRAFT THAT CONSISTED OF A PDS FLEXIBLE PLATE ENVELOPED IN TEMPOROPARIETAL FASCIA VIA A HEMITRANSFIXION INCISION WAS FEASIBLE AND RESULTED IN COMPLETE MUCOSAL CLOSURE OF NASAL SEPTAL PERFORATIONS IN MOST PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1144475 PDS PLATE UNKNOWN PRODUCT POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE NHB ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention