BEUDAMED
    FDA Adverse Event Summary report: N

    1.5MM RAPID RESORB ORBITAL FLOOR PLATE

    MDR report key: 1894150 · Received November 4, 2010

    Report

    Report Number
    1719045-2010-00321
    Date Received
    November 4, 2010
    Report Date
    October 5, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JEY
    PMA / PMN Number
    K030069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFO WAS NOT PROVIDED DURING INITIAL REPORT. ADDITIONAL INFO HAS BEEN REQUESTED. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MFG DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    PT IMPLANTED WITH RAPIDSORB ORBITAL FLOOR PLATES FOR AN ORBITAL FLOOR BLOW OUT. POSTOPERATIVELY, PT REPORTEDLY REJECTED PLATE AND IMPLANT WAS REMOVED. NO REPORTED INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.5MM RAPID RESORB ORBITAL FLOOR PLATE RAPID RESORB ORBITAL FLOOR PLATE JEY SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention