BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELIX ACP SYSTEM

    MDR report key: 2041468 · Received March 10, 2011

    Report

    Report Number
    2031966-2011-00009
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Report Date
    March 7, 2011
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K071329
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITTLE OR NO SPECIFIC INFORMATION IS KNOWN REGARDING THE EVENT AT THIS TIME. THE SURGEON HAS ELECTED TO MONITOR THE PATIENT; NO REVISION SURGERY HAS OCCURRED AT THIS TIME. WHEN RELEVANT INFORMATION IS AVAILABLE, INCLUDING ANY DEVICE EVALUATION, A FOLLOW-UP REPORT WILL BE FILED. REVIEW OF LABELING NOTES THE FOLLOWING: "POTENTIAL RISK IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: BENDING, FRACTURE OR LOOSENING OF IMPLANT COMPONENT(S). NONUNION OR DELAYED UNION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN TWO CASES OF ACDF, UTILIZING THE HELIX PLATE, THE ONE OF TWO INFERIOR SCREWS LOOSENED IN A 3-LEVEL CONSTRUCT. SURGEON HAS ELECTED TO MONITOR THE PATIENTS AND REVISION SURGERY HAS NOT YET OCCURRED. NO OTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other