BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS PLATE UNKNOWN PRODUCT

    MDR report key: 9220750 · Received October 22, 2019

    Report

    Report Number
    2210968-2019-88937
    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
    FI
    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: INT. J. ORAL MAXILLOFAC. SURG. 2001; 30: 278¿285 / DOI:10.1054/IJOM.2001.0067. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: EFFECTIVENESS OF OPERATIVE TREATMENT OF INTERNAL ORBITAL WALL FRACTURE WITH POLYDIOXANONE IMPLANT" AUTHOR(S): R. KONTIO, R. SUURONEN, O. SALONEN, P. PAUKKU, Y. T. KONTTINEN, C. LINDQVIST CITATION: INT. J. ORAL MAXILLOFAC. SURG. 2001; 30: 278¿285 / DOI:10.1054/IJOM.2001.0067 . THE PURPOSE OF THIS PROSPECTIVE STUDY WAS TO DETERMINE WHETHER PDS IMPLANTS USED FOR ORBITAL BONE RECONSTRUCTION ADEQUATELY SUPPORTED SOFT TISSUE, AND WHETHER USE OF PDS IMPLANTS ALLOWED RESHAPING OF FRACTURED ORBITAL FLOORS. A TOTAL OF 16 PATIENTS [(N=11 MALE, MEAN AGE 39.2 YEARS (RANGE 18.0-58.9 YEARS)), N=5 FEMALE, MEAN AGE 31.3 YEARS (RANGE 20.1-53.2 YEARS))] WITH BLOWN-OUT FRACTURES UNDERWENT INTERNAL ORBITAL WALL RECONSTRUCTION. AFTER REPOSITIONING OF ORBITAL CONTENT, EACH FLOOR WAS RECONSTRUCTED USING A ROUND PLATE OR SHEET OF PDS (ETHICON). THREE PLATES AND THREE SHEETS WERE EACH FIXED BY MEANS OF TWO 5-MM AO MICRO-SCREWS (DIAMETER 1 MM), THE REST BY MEANS OF TWO PDS 4-0 SUTURES IN THE INFRAORBITAL RIM. POSTOPERATIVE COMPLICATIONS INCLUDED ECTROPION OF THE LOWER EYELID (N=2) WHERE OPERATION HAD TAKEN PLACE IN BOTH PATIENTS VIA A SUBCILIARY APPROACH, THE ECTROPION RESOLVED IN BOTH CASES DURING THE STUDY; POSSIBLE ORBITONASAL FISTULA WITHOUT CLINICAL SYMPTOMS (N=1); THICK SCAR FORMATION (N=6); FIBROTIC SINUSES FILLED WITH AIR OR GAS (N=3); FIBROTIC SINUS WITH FLUID FORMED AROUND A PDS PLATE (N=1); AND LARGE CYSTIC SINUS FORMATION INSIDE THE ORBIT AND PHLEGM RETENTION IN MAXILLARY SINUS (N=1). OUR FINDINGS STRONGLY SUPPORT THE IDEA THAT BONE GRAFTING MIGHT BE BETTER THAN USE OF PDS PLATES WHEN RECONSTRUCTION OF AN INTERNAL ORBITAL WALL IS NEEDED. OUR RESULTS SUGGEST THAT USE OF PDS IN RECONSTRUCTING THE INTERNAL ORBITAL WALL IS INADVISABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015017 PDS PLATE UNKNOWN PRODUCT POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE NHB ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention