BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS PLATE UNKNOWN PRODUCT

    MDR report key: 9220872 · Received October 22, 2019

    Report

    Report Number
    2210968-2019-88939
    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 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: J ORAL MAXILLOFAC SURG (2005); 63:492-498. DOI: 10.1016/J.JOMS.2004.12.004. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : A NOVEL HIGH-RESOLUTION MAGNETIC RESONANCE IMAGING MICROSCOPY COIL AS AN ALTERNATIVE TO THE MULTISLICE COMPUTED TOMOGRAPHY IN POSTOPERATIVE IMAGING OF ORBITAL FRACTURES AND COMPUTER-BASED VOLUME MEASUREMENT" AUTHORS : ANDREAS KOLK, MD, DMD,* CHRISTOPH PAUTKE, MD, DMD,¿ EDZARD WIENER, MD,¿ OLIVER PLODER, MD, DMD, PHD,§ AND ANDREAS NEFF, MD, DMD, PHD CITATION: J ORAL MAXILLOFAC SURG (2005); 63:492-498. DOI: 10.1016/J.JOMS.2004.12.004. THE AIM OF THIS PROSPECTIVE STUDY WAS TO EVALUATE HIGH RESOLUTION MAGNETIC RESONANCE IMAGING (MRI) WITH A NOVEL MICROSCOPY COIL COMPARED WITH THE CONVENTIONAL MRI HEAD COIL (MRIHC) AND MULTISLICE COMPUTED TOMOGRAPHY (MSCT) IN THE ASSESSMENT OF THE FUNCTIONAL OUTCOME AFTER ORBITAL FRACTURE AND THE DECISION FOR REVISION SURGERY THIS PROSPECTIVE STUDY INVOLVES 32 PATIENTS (22 MALE AND 10 FEMALE; MEAN AGE: 28.6 YEARS; AGE RANGE: 17-53 YEARS) WITH EXTENDED ORBITAL WALL FRACTURES (N-36) WHO WERE TREATED SURGICALLY USING A POLYDIOXANONSULFATE (PDS) FOIL (ETHICON) AFTER RECONSTRUCTION BETWEEN JANUARY 2002 AND OCTOBER 2003. POSTOPERATIVELY, IMAGING WAS PERFORMED USING MRIMC, CONVENTIONAL MRI, AND MSCT TO EVALUATE THE DIFFERENT IMAGING TECHNIQUES. STANDARD COVERAGE OF THE FRACTURED AREA WAS ATTAINED BY 1 OR 2 RESORBABLE, BIODEGRADABLE PDS FOILS (ETHICON) WITH A THICKNESS OF 0.25 MM OR 0.5 MM. REPORTED COMPLICATIONS INCLUDED PDS-FOIL DISLOCATION WITH >=0.65 CM3 TISSUE HERNIATION (N-5) WITH CLINICAL SYMPTOMS OF ENOPHTHALMOS (N-3), MOTILITY DEFICIT (N-4), PATHOLOGIC GLOBE POSITION (N-2), AND DIPLOPIA (N-5) IN WHICH 5 PATIENTS UNDERWENT SECOND SURGERY; TISSUE DISPLACEMENT DUE TO INADEQUATE FRACTURE COVERAGE (N-6) WITH CLINICAL SYMPTOMS ENOPHTHALMOS (N-6), MOTILITY DEFICIT (N-5), AND DIPLOPIA (N-6) IN 6 PATIENTS UNDERWENT SECOND SURGERY; AND MUSCLE EDEMA (N-8) WITH CLINICAL SYMPTOMS OF MOTILITY DEFICIT (N-4), PATHOLOGIC GLOBE POSITION (N-1), AND DIPLOPIA (N-6). IN CONCLUSION, MRIMC PROVED TO BE HIGHLY SUPERIOR TO MRIHC AND MSCT IN POSTSURGICAL ORBITAL IMAGING, ESPECIALLY FOR DECISION MAKING REGARDING REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015254 PDS PLATE UNKNOWN PRODUCT POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE NHB ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention