BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS PLATE UNKNOWN PRODUCT

    MDR report key: 7118709 · Received December 14, 2017

    Report

    Report Number
    2210968-2017-71796
    Event Type
    Injury
    Date Received
    December 14, 2017
    Report Date
    November 24, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    NHB
    PMA / PMN Number
    K092590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A 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 PRODUCT ETHISORB OR PDS PLATE CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE? CAN SPECIFIC PATIENT DEMOGRAPHICS BE PROVIDED FOR THE SUBJECTS OF THIS ARTICLE? IF SO, PLEASE ALSO INCLUDE: PATIENT INITIALS, INITIAL PROCEDURE DATE, PRE-EXISTING CONDITIONS, SPECIFIC MEDICAL/SURGICAL INTERVENTION PER PATIENT. IS THE PRODUCT CODE AND LOT NUMBER AVAILABLE FOR ANY OF THE ETHICON DEVICES USED? CITATION: CLIN ORAL INVEST (2011) 15:305¿313. DOI 10.1007/S00784-010-0385-Y.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A JOURNAL ARTICLE (TITLE: RETROSPECTIVE ANALYSIS OF ORBITAL FLOOR FRACTURES¿COMPLICATIONS, OUTCOME, AND REVIEW OF LITERATURE) THAT A PATIENT UNDERWENT PRIMARY ORBITAL FLOOR RECONSTRUCTION ON UNKNOWN DATE AND DEVICE WAS USED FOR STANDARD ORBITAL FLOOR REPAIR. A RETROSPECTIVE REVIEW OF ORBITAL RECONSTRUCTION PROCEDURES PERFORMED BETWEEN (B)(6) 2003 AND (B)(6) 2007. THE PATIENT POSSIBLY EXPERIENCED DIPLOPIA, MOTILITY IMPAIRMENT, ENOPHTHALMOS/HYPOPHTHALMUS OR INFECTION. THE PATIENT POSSIBLY REQUIRED REVISION SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898183 PDS PLATE UNKNOWN PRODUCT POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE NHB ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention