BEUDAMED
    FDA Adverse Event Death Summary report: N

    PYRAMESH C TITANIUM MESH

    MDR report key: 2505689 · Received March 27, 2012

    Report

    Report Number
    1030489-2012-00361
    Event Type
    Death
    Date Received
    March 27, 2012
    Date of Event
    October 14, 2011
    Report Date
    March 1, 2012
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    EZX
    PMA / PMN Number
    K011406
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE OR APPLICABLE IMAGING STUDIES WERE NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TITANIUM ANTERIOR CERVICAL PLATE AND TITANIUM MESH INTERBODY DEVICE. POST-OP DAY ONE THE PATIENT REPORTEDLY HAD LARYNGEAL EDEMA AND UNDERWENT ADDITIONAL SURGERY TO RELIEVE THE SYMPTOMS. POST-OP DAY, TWO THE PATIENT REPORTEDLY DIED DUE TO CEREBRAL EDEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PYRAMESH C TITANIUM MESH MESH, METAL EZX WARSAW ORTHOPEDICS NA 0073552W

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Death