BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VUEPOINT OCT SYSTEM

    MDR report key: 1983691 · Received February 3, 2011

    Report

    Report Number
    2031966-2011-00005
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    January 3, 2011
    Report Date
    February 2, 2011
    Manufacturer
    NUVASIVE, INC.
    Product Code
    MNI
    PMA / PMN Number
    K071435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPLANTED CONSTRUCT HAS NOT BEEN RETURNED TO DATE BUT IS AVAILABLE FOR EVAL. THERE IS NO DISCERNIBLE TREND ASSOCIATED WITH THIS PRODUCT AND THE REPORTED EVENT TYPE. PT POST-OPERATIVE ACTIVITY LEVELS AND/OR COMPLIANCE WITH POST-OPERATIVE CARE INSTRUCTIONS IS UNK AT THIS TIME. A F/U REPORT WILL BE FILED WHEN NEW RELEVANT INFO IS AVAILABLE. LABELING REVIEW NOTES THE FOLLOWING: "POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS DEVICE SYSTEM, WHICH MAY REQUIRE ADDITIONAL 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 NONUNION. 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

    POST-OPERATIVE BREAKAGE OF VUEPOINT SCREWS OCCURRED IN A PT WHO HAD PREVIOUSLY RECEIVED TWO FUSION SURGERIES AT C2. IN ADDITION, PRIOR ACDF HAD OCCURRED AT C3-C4 AND C6-C7. CURRENT CONSTRUCT INCLUDES OCCIPITAL PLATE PLACEMENT WITH ADJACENT ANCHORING AT C2. REVISION OCCURRED ON (B)(6) 2011. THE EXISTING RODS AND SCREWS WERE REMOVED AND REPLACED; THE CONSTRUCT NOW EXTENDS FROM THE C2 THROUGH C5 VERTEBRAL BODIES. THE OCCIPITAL PLATE WAS RETAINED AND THE REMAINING CONSTRUCT WAS ATTACHED TO IT. THE PT IS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VUEPOINT OCT SYSTEM SPINAL INTERLAMINAL FIXATION ORTHOSIS MNI NUVASIVE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention