BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VUEPOINT OCT SYSTEM

    MDR report key: 3080788 · Received April 11, 2013

    Report

    Report Number
    2031966-2013-00016
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 12, 2013
    Report Date
    April 11, 2013
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWP
    PMA / PMN Number
    K093319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AMOUNT OF TIME BETWEEN INITIAL SURGERY AND THE REPORTED ISSUE SUGGESTS THAT DELAYED UNION OR THE PT'S POST-SURGERY ACTIVITY LEVELS MAY BE CONTRIBUTING FACTORS TO THE REPORTED EVENT. THE IMPLANTED PRODUCT HAS NOT BEEN RETURNED FOR EVAL AND NO REVISION SURGERY IS PLANNED AT THIS TIME. SHOULD THE PRODUCT BE RETURNED, INVESTIGATION WILL RESUME AND ANY RELEVANT INFO WILL BE REPORTED. LABELING REVIEW NOTED THE FOLLOWING: "POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS DEVICE SYSTEM, WHICH MAY REQUIRE ADD'L SURGERY, INCLUDE: DEVICE COMPONENT FRACTURE, LOSS OF FIXATION, NON-UNION, FRACTURE OF THE VERTEBRA, NEUROLOGICAL INJURY, AND VASCULAR OR VISCERAL INJURY." "THESE DEVICES CAN BREAK WHEN SUBJECTED TO THE INCREASED LOAD ASSOCIATED WITH DELAYED UNION OR NON-UNION. INTERNAL FIXATION APPLIANCES ARE LOAD-SHARING DEVICES THAT HOLD BONY STRUCTURES IN ALIGNMENT UNTIL HEALING OCCURS. IF HEALING IS DELAYED, OR DOES NOT OCCUR, THE IMPLANT MAY EVENTUALLY LOOSEN, BEND, OR BREAK. LOADS ON THE DEVICE PRODUCED BY LOAD BEARING AND BY THE PT'S ACTIVITY LEVEL WILL DICTATE THE LONGEVITY OF THE IMPLANT."

    Description of Event or Problem · 1

    A POSTERIOR CERVICAL FUSION WITH VUEPOINT FIXATION WAS PERFORMED ON (B)(6) 2012. THE CONSTRUCT APPEARS TO EXTEND FROM THE C3 TO C7 VERTEBRAL BODIES. RADIOGRAPHS TAKEN DURING A ROUTINE F/U VISIT AND PROVIDED TO NUVASIVE ON (B)(6) 2013 DEPICTED A FRACTURE NEAR THE NECK OF THE SCREW IN THE C4 VERTEBRAL BODY. THE SHANK REMAINS EMBEDDED IN BONE AND NO MIGRATION OF IMPLANT COMPONENTS HAS BEEN REPORTED TO HAVE OCCURRED. THE PT IS REPORTEDLY ASYMPTOMATIC AND THE SURGEON HAS NO PLANS FOR REVISION SURGERY AT THIS TIME. THE PT WILL CONTINUE TO BE MONITORED RADIOGRAPHICALLY BY THE SURGEON TO DETERMINE WHEN OR IF ADD'L SURGERY IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155829 VUEPOINT OCT SYSTEM SPINAL INTERLAMINAL FIXATION ORTHOSIS KWP NUVASIVE, INC. 7905312 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other