BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.3MM TI ORBITAL RIM PLATE 9 HOLES

    MDR report key: 3173621 · Received June 17, 2013

    Report

    Report Number
    2520274-2013-03461
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    JEY
    PMA / PMN Number
    K953806
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND A LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    A BROKEN NINE HOLED IMPLANTED PLATE WAS REMOVED ABOUT ONE MONTH AGO. ON (B)(6) 2013, THE OLD PLATE WAS REPLACED WITH A LARGER PLATE LOCATED ON THE RIGHT ZYGOMATIC MAXILLARY FRONTAL (ZF) BONE SUTURE. THIS IS REPORT 1 OF 1 FOR COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273143 1.3MM TI ORBITAL RIM PLATE 9 HOLES BONE, PLATE JEY SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention