BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELIX REVOLUTION ACP SYSTEM

    MDR report key: 2212037 · Received July 8, 2011

    Report

    Report Number
    2031966-2011-00032
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K093804
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REVISION SURGERY HAS NOT YET OCCURRED; NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. NO ROOT CAUSE HAS YET BEEN IDENTIFIED. SHOULD REVISION SURGERY OCCUR AND PRODUCT BECOME AVAILABLE, ADDITIONAL RELEVANT INFORMATION WILL BE INCLUDED IN A SUBSEQUENT REPORT. LABELING REVIEW NOTES THE FOLLOWING: "POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: BENDING, FRACTURE OR LOOSENING OF IMPLANT COMPONENT(S)."

    Description of Event or Problem · 1

    APPROXIMATELY 3 WEEKS AFTER IMPLANTATION OF A 2-LEVEL HELIX REVOLUTION PLATE, THE RIGHT INFERIOR SCREW HAS BACKED OUT A SMALL AMOUNT. THE SURGEON REPORTED THAT IN ADDITION TO THE RIGHT CENTER SCREW WAS NOT FULLY LOCKED DOWN BASED UPON RADIOGRAPHIC REVIEW, BUT HAS NOT BECOME LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HELIX REVOLUTION ACP SYSTEM SPINAL INT VERT BODY FIXATION ORTHOSIS KWQ NUVASIVE, INC. 7801113 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR