BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORBITAL FLOOR PLATE

    MDR report key: 5537490 · Received March 28, 2016

    Report

    Report Number
    MW5061351
    Event Type
    Injury
    Date Received
    March 28, 2016
    Date of Event
    March 15, 2016
    Report Date
    March 28, 2016
    Manufacturer
    SYNTHES
    Product Code
    JEY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    EXPIRATION DATE ON EXTERNAL PACKAGING SHOWS DATE OF EXPIRATION OF 05/2020. EXPIRATION DATE ON ACTUAL IMPLANT SHOWS: 08/2015. EXTERNAL PACKAGING OF TWO IMPLANTS - LOTS # 6913455 SHOWED EXP. DATES OF 05/2020. INTERNAL PACKAGING, LOT # 2770707 SHOWED EXPIRATION DATES TO BE: 08/2015. MEDICAL RECORD STICKERS DISPLAYED LOT # 6913455 WITH EXP. DATES OF 05/2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186712 ORBITAL FLOOR PLATE ORBITAL FLOOR PLATE JEY SYNTHES 6913455, 2770707

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention