BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AP EXPANDABLE XLIF SYSTEM

    MDR report key: 6137223 · Received November 30, 2016

    Report

    Report Number
    2031966-2016-00085
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Report Date
    November 30, 2016
    Manufacturer
    NUVASIVE, INC.
    Product Code
    MAX
    UDI-DI
    00887517454072
    PMA / PMN Number
    K140162
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR THE RADIOGRAPHS WERE RECEIVED FOR REVIEW. NO INFORMATION REGARDING THE INITIAL OR REMOVAL SURGERY WAS PROVIDED. ROOT CAUSE HAS NOT BEEN DETERMINED AND NO CONCLUSION CAN BE DRAWN. THE PATIENT REPORTEDLY REQUESTED THE EXPLANTED DEVICE BE GIVEN TO THEM. THE IMPLANT IS NOT CURRENTLY AVAILABLE FOR EVALUATION. REVIEW OF LABELING NOTES: "POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: BENDING, FRACTURE OR LOOSENING OF IMPLANT COMPONENT(S), LOSS OF FIXATION, NONUNION OR DELAYED UNION, FRACTURE OF THE VERTEBRA, NEUROLOGICAL, VASCULAR OR VISCERAL INJURY, METAL SENSITIVITY OR ALLERGIC REACTION TO A FOREIGN BODY, INFECTION, DECREASE IN BONE DENSITY DUE TO STRESS SHIELDING, PAIN, DISCOMFORT OR ABNORMAL SENSATIONS DUE TO THE PRESENCE OF THE DEVICE, NERVE DAMAGE DUE TO SURGICAL TRAUMA, BURSITIS, DURAL LEAK, PARALYSIS AND DEATH." DEVICE NOT RECEIVED.

    Description of Event or Problem · 1

    ON (B)(6) 2016 IT WAS REPORTED THAT A SURGEON REMOVED AN IMPLANT FROM A PATIENT. NO REASON FOR THE REMOVAL WAS PROVIDED. NO OTHER INFORMATION RELATED TO THE EVENT WAS PROVIDED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786956 AP EXPANDABLE XLIF SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX NUVASIVE, INC. 1672392 00887517454072

    Patients

    Seq Age Sex Outcome Treatment
    1