BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARTEVIEW ANTERIOR CERVICAL PLATE

    MDR report key: 1625292 · Received March 3, 2010

    Report

    Report Number
    3003855635-2010-00005
    Event Type
    Malfunction
    Date Received
    March 3, 2010
    Date of Event
    February 2, 2010
    Report Date
    February 26, 2010
    Manufacturer
    ATLAS SPINE INC.
    Product Code
    KWQ
    PMA / PMN Number
    K050588
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WAS PROVIDED BY THE DOCTOR, HE STATED THAT THE LOWER PORTION OF THE PLATE AND THE LOWER SCREWS WERE RAISED OFF THE SPINE AND COULD HAVE CONTRIBUTED TO THE PATIENT'S DISCOMFORT WHEN SWALLOWING. HE ALSO STATED THAT THE PLATE AND SCREWS RAISING OFF THE SPINE COULD BE CONTRIBUTED TO ANY NUMBER OF THINGS, UNREPORTED TRAUMA, OVER FLEXION OR EXTENSION, LOAD SHARING DYNAMIC CHANGING AS THE FUSION MASS SUPPORTED MORE AND MORE OF THE PHYSIOLOGIC LOADS, ETC.

    Description of Event or Problem · 1

    DOCTOR DID A REVISION SURGERY TO REMOVE A ONE LEVEL PLATE THAT WAS IMPLANTED OVER A YEAR AGO. PT COMPLAINED OF DISCOMFORT SWALLOWING. DOCTOR FOUND TWO CAUDAL RESCUE SCREWS ON THE PLATE HAD POPPED OUT OF THE BONE. DOCTOR STATED THAT THE PT HAD GOOD FUSION AND THAT NO REPLACEMENT HARDWARE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARTEVIEW ANTERIOR CERVICAL PLATE SPINAL INTERVERTEBRAL BODY FIXATION ORT KWQ ATLAS SPINE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention