BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PYRAMESH

    MDR report key: 5109962 · Received September 29, 2015

    Report

    Report Number
    1030489-2015-02512
    Event Type
    Injury
    Date Received
    September 29, 2015
    Date of Event
    September 10, 2015
    Report Date
    September 10, 2015
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    EZX
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG NUMBER 905-137 AND 510K NUMBER K011406 IS APPROVED FOR SALE IN US. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE CAUSE OF EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT 2-ABOVE 2-BELOW FIXATION WITH SPINAL SYSTEM FOR COMPRESSION FRACTURE AT L4 ON (B)(6) 2015. CORPECTOMY WAS ALSO PERFORMED AT L4 WITH A CAGE. ON AN UNKNOWN DATE POST-OP, THE CAGE WAS FOUND TO BE MIGRATED INTO SPINAL CANAL. EMERGENCY REVISION WAS PERFORMED ON (B)(6) 2015, TO REMOVE THE CAGE AND TO PERFORM BONE GRAFTING AND COMPRESSION. INFECTION WAS ALSO FOUND. AS PER DOCTOR, INFECTION CAUSED DISLOCATION OF THE CAGE. INFECTION WAS NOT PROBLEM OF IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641202 PYRAMESH MESH, METAL EZX WARSAW ORTHOPEDICS G905H137 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention