BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRANSITIONAL HELIX ACP SYSTEM

    MDR report key: 3766815 · Received April 10, 2014

    Report

    Report Number
    2031966-2014-00024
    Event Type
    Other
    Date Received
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K083341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RADIOGRAPH WERE RECEIVED DEPICTING POSSIBLE LACK OF UNION SUPERIOR END PLATE OF THE C4 VERTEBRAL BODY. ALLOGRAFT AT C4-C5 APPEARS TO HAVE PARTIALLY COLLAPSED, BUT NO MAJOR SHIFT IN THE CONSTRUCT OCCURRED. PT IS ASYMPTOMATIC. SCREWS REMAIN IN THE PT, AND NO FURTHER EVAL OF THE PRODUCT CAN BE COMPLETED AT THIS TIME. THOUGH THERE WERE POSSIBLE CONTRIBUTORS (PHYSIOLOGICAL CHANGES AND A POSSIBLE NON-UNION), THE ROOT CAUSE OF THIS REPORTED EVENT HAS NOT BEEN DETERMINED; NO CONCLUSION CAN BE DRAWN. 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."

    Description of Event or Problem · 1

    IN (B)(6) 2014, IT WAS DISCOVERED THAT THE ANTERIOR CERVICAL PLATE BONE SCREW REPORTEDLY BACK OUT INSIDE THE C5 VERTEBRAL BODY. INITIAL C3-C5 (TWO LEVEL) ACDF WAS PERFORMED ON (B)(6) 2012. DURING THE INITIAL THREE MONTH FOLLOW UP THERE WERE NO NOTABLE CHANGES IN THE RADIOGRAPH. NO ADDITIONAL RADIOGRAPHICAL DATA WAS RECEIVED DURING THE 18 MONTHS POST FOLLOW UP. THE EVENT DATE REMAINS UNCLEAR. THE EVENT WAS OBSERVED ON RADIOGRAPHS DATED ON (B)(6) 2014. PT'S ACTIVITY LEVEL IS UNK. PT COMPLIANCE WITH POST SURGICAL INSTRUCTIONS IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219259 TRANSITIONAL HELIX ACP SYSTEM SPINAL INT VERT BODY FIXATION ORTHOSIS KWQ NUVASIVE, INC. 7735311 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR