BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM

    MDR report key: 3178254 · Received June 19, 2013

    Report

    Report Number
    2520274-2013-03584
    Event Type
    Injury
    Date Received
    June 19, 2013
    Report Date
    May 23, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    K083388
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: DZL. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    THE PATIENT WAS ORIGINALLY IMPLANTED WITH AN ORBITAL FLOOR IMPLANT ON (B)(6) 2012 AND RETURNED TO THE O.R. ON (B)(6) 2013 FOR REMOVAL OF THE IMPLANT DUE TO LESS THAN OPTIMAL POSITION OF THE GLOBE. THE PATIENT WAS REVISED TO SYNPOR TI FAN PLATE MODIFIED WITH MEDPOR WHEN IMPLANTED. THE PATIENT'S OUTCOME WAS REPORTED AS FAVORABLE. THIS IS 2 OF 4 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277570 TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention