BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SST EZ SPHERE - 22MM

    MDR report key: 6992067 · Received October 31, 2017

    Report

    Report Number
    0008010177-2017-00271
    Event Type
    Injury
    Date Received
    October 31, 2017
    Date of Event
    March 21, 2017
    Report Date
    October 31, 2017
    Manufacturer
    STRYKER ORTHOBIOLOGICS-MALVERN
    Product Code
    FWP
    PMA / PMN Number
    K922489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    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 REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY HOSPITAL PHARMACIST THROUGH A COMPANY REPRESENTATIVE THAT A PATIENT DEVELOPED A POSSIBLE POST-SURGICAL INFECTION RELATED TO A MAJOR ORBITAL INFLAMMATORY SYNDROME AFTER A SURGICAL PROCEDURE WITH AN IMPLANT. THE PROCEDURE HAD BEEN COMPLETED SUCCESSFULLY WITHOUT A DELAY. IT WAS REPORTED THE PATIENT RETURNED TO THE HOSPITAL AND ADDITIONAL MEDICAL INTERVENTION WAS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771269 SST EZ SPHERE - 22MM IMPLANT FWP STRYKER ORTHOBIOLOGICS-MALVERN A1604055

    Patients

    Seq Age Sex Outcome Treatment
    1