BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VUEPOINT OCT SYSTEM

    MDR report key: 3072225 · Received March 6, 2013

    Report

    Report Number
    2031966-2013-00011
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Report Date
    March 5, 2013
    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

    (B)(4). THE PT UNDERWENT A PRIOR ANTERIOR CERVICAL FUSION; THE FUSION WAS NOT SUCCESSFUL (PSEUDOARTHROSIS). THE SURGEON SUBSEQUENTLY DETERMINED POSTERIOR CERVICAL FUSION WAS INDICATED. THE POSTERIOR PROCEDURE WAS COMPLETED ON (B)(6) 2013. AT THE TIME OF INITIAL FOLLOW-UP OFFICE VISIT, IT WAS DETERMINED THAT THE COMPONENTS OF A SCREW ASSEMBLY HAD SEPARATED. REVISION SURGERY WAS REPORTED TO HAVE OCCURRED ON (B)(6) 2013; IT IS UNKNOWN HOW THE CONSTRUCT WAS MODIFIED. THE ROOT CAUSE HAS NOT BEEN IDENTIFIED. 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

    FOLLOWING IMPLANTATION OF A POSTERIOR CERVICAL CONSTRUCT, SEPARATION OF SCREW COMPONENTS WAS REPORTED. REVISION SURGERY TO CORRECT THE PROBLEM OCCURRED ON (B)(6) 2013. NO PT INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96562 VUEPOINT OCT SYSTEM SPINAL INTERLAMINAL FIXATION ORTHOSIS MNI NUVASIVE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1