BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PYRAMESH

    MDR report key: 186129 · Received September 8, 1998

    Report

    Report Number
    1030489-1998-00070
    Event Type
    Injury
    Date Received
    September 8, 1998
    Date of Event
    August 11, 1998
    Report Date
    August 11, 1998
    Manufacturer
    SOFAMOR DANEK MFG.
    Product Code
    EZK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED ON 06/09/1998. X-RAYS WERE TAKEN DUE TO COMPLAINTS OF PAIN. X-RAYS REVEALED THAT A SECTION OF THE DEVICE WAS BROKEN. REVISION SURGERY WAS PERFORMED ON 08/11/98 TO REMOVE AND REPLACE THE DEVICE. IT WAS REPORTED THAT THE DEVICE WAS BROKEN AND DEFORMED. IT IS UNKNOWN AT WHAT TIME THE FRACTURE AND DEFORMATION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PYRAMESH Implant MESH, METAL EZK SOFAMOR DANEK MFG. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention