BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS PLATE UNKNOWN PRODUCT

    MDR report key: 9220827 · Received October 22, 2019

    Report

    Report Number
    2210968-2019-88938
    Event Type
    Injury
    Date Received
    October 22, 2019
    Report Date
    September 25, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    NHB
    PMA / PMN Number
    K092590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. CITATION: ARCH FACIAL PLAST SURG. 2012;14(5):323-330. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: VERSATILE APPLICATIONS OF THE POLYDIOXANONE PLATE" IN RHINOPLASTY AND SEPTAL SURGERY. AUTHORS : JOANNE RIMMER, FRCS (ORL-HNS); LOUISA M. FERGUSON, MRCS, DOHNS; HESHAM A. SALEH, FRCS (ORL-HNS). CITATION: ARCH FACIAL PLAST SURG. 2012;14(5):323-330. THIS RETROSPECTIVE STUDY AIMS TO DESCRIBE THE USE OF A POLYDIOXANONE PLATE NOT ONLY AS A TEMPLATE IN EXTRACORPOREAL SEPTOPLASTY BUT ALSO FOR VARIOUS OTHER GRAFTS COMMONLY USED IN RHINOPLASTY AND FOR THE REPAIR OF SEPTAL PERFORATIONS. BETWEEN 01NOV2007 AND 28FEB2011, POLYDIAXANONE (PDS) PLATE (ETHICON) WAS USED IN SEPTAL AND/OR RHINOPLASTY SURGERY IN 102 PATIENTS (MALE=69, FEMALE=33; MEAN AGE=36.5 YEARS, AGE RANGE=20-63 YEARS). 29 PATIENTS UNDERWENT AN EXTRACORPOREAL SEPTOPLASTY USING A PDS PLATE AS A SCAFFOLD; THE TECHNIQUE USES A 0.15 MM PERFORATED PDS PLATE TEMPLATE OF THE NASAL SEPTUM. 16 PATIENTS UNDERWENT ENDONASAL SEPTOPLASTY AND 39 PATIENTS UNDERWENT SEPTORHINOPLASTY, WITH OR WITHOUT A COLUMELLAR STRUT; 13 PATIENTS UNDERWENT SEPTAL PERFORATIONS USING A PDS PLATE AS THE MIDDLE SUPPORTING LAYER BETWEEN THE 2 MUCOSAL FLAPS. OF THESE PERFORATIONS, 7 WERE SMALLER THAN 15MMIN DIAMETER AND WERE REPAIRED USING A PDS PLATE ALONE AND 6 WERE LARGER THAN 15MM AND WERE REPAIRED USING A PDS PLATE. SOME PATIENTS DID NOT ATTEND PLANNED FOLLOW-UP APPOINTMENTS ONCE THEY FELT THAT THINGS WERE SATISFACTORY. POSTOPERATIVE COMPLICATIONS INCLUDED FAILURE OF SEPTAL PERFORATION REPAIR (N=3) IN WHICH 2 OF THE 3 PATIENTS HAD UNDERGONE REVISION PROCEDURES USING A PDS PLATE ALONE AFTER FAILED REPAIRS, AND THE THIRD FAILURE OCCURRED AFTER FURTHER SEPTAL TRAUMA DUE TO COCAINE USE; A PDS PLATE AND CARTILAGE HAD BEEN USED TO REPAIR A 3-CM PERFORATION. THIS PATIENT WAS NOT BELIEVED TO BE SUITABLE FOR FURTHER SURGERY, BUT THE OTHER 2 WENT ON TO HAVE SUCCESSFUL CLOSURE PERFORMED VIA A FORMAL EXTERNAL SEPTORHINOPLASTY APPROACH, AGAIN USING A PDS PLATE ALONE; MINOR SWELLING OF THE SEPTUM AT 6 WEEKS (N=15) RESULTING IN A VARIABLE DEGREE OF ONGOING NASAL BLOCKAGE. THESE PATIENTS WERE TREATED WITH FLUTICASONE PROPIONATE NASAL SPRAY FOR 6 WEEKS, AND THE SWELLING HAD RESOLVED IN MOST PATIENTS BY 3 MONTHS AND THAT ALL PATIENTS WERE SATISFIED; POSTOPERATIVE INFECTION WITH SUBSEQUENT EXTRUSION OF THE UNPERFORATED PDS (N=1) IN WHICH THE INFECTION WAS SUCCESSFULLY TREATED WITH ORAL ANTIBIOTICS; SEVERE INFECTION WITH ULTIMATE NASAL DORSAL COLLAPSE (N=1) DESPITE TREATMENT WITH INTRAVENOUS ANTIBIOTICS. IN CONCLUSION, THE PDS PLATE SEEMS TO BE AN IDEAL GRAFT CHOICE TO PROVIDE SUPPORT AND STABILITY TO REGENERATING HEALING CARTILAGE IN THE SEPTUM AND IN OTHER AREAS OF THE NOSE. IT PROVIDES A STRUCTURAL TEMPLATE TO WHICH IT IS EASY TO ATTACH CARTILAGE, EVEN SMALL PIECES, AND IT FACILITATES THE INSERTION OF SUCH GRAFTS INTO THE NOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013443 PDS PLATE UNKNOWN PRODUCT POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE NHB ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention