BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR TITAN OFW - BTB - 41MM

    MDR report key: 7629641 · Received June 22, 2018

    Report

    Report Number
    0008010177-2018-00053
    Event Type
    Injury
    Date Received
    June 22, 2018
    Date of Event
    May 25, 2018
    Report Date
    June 22, 2018
    Manufacturer
    STRYKER ORTHOBIOLOGICS-MALVERN
    Product Code
    FTL
    UDI-DI
    07613252084341
    PMA / PMN Number
    K040364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE DISCARDED AT FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ORBITAL FLOOR PLATE HAD TO BE REMOVED BECAUSE THE PATIENT STARTED TO EXPERIENCE DOUBLE VISION FOLLOWING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472007 MEDPOR TITAN OFW - BTB - 41MM IMPLANT FTL STRYKER ORTHOBIOLOGICS-MALVERN UNKNOWN 07613252084341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other