BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HELIX-T ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 2881178 · Received November 15, 2012

    Report

    Report Number
    2031966-2012-00052
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    September 27, 2012
    Report Date
    November 12, 2012
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K083341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED EVENT WAS CONFIRMED VIA RADIOGRAPH. REVISION SURGERY HAS REPORTEDLY NOT OCCURRED. AS OF THIS REPORT DATE, THE PRODUCT REMAINS IMPLANTED AND UNAVAILABLE FOR FURTHER ANALYSIS. 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).

    Description of Event or Problem · 1

    FOLLOWING IMPLANTATION OF A 3-LEVEL ANTERIOR CERVICAL PLATE AT THE C3-C6 SPINE LEVELS, THE LEFT INFERIOR SCREW WAS NOTED TO HAVE LOOSENED DURING A FOLLOW-UP OFFICE VISIT. NO INJURY OCCURRED AND NO REVISION SURGERY HAS OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HELIX-T ANTERIOR CERVICAL PLATE SYSTEM SPINAL INTERVERT BODY FIXATION ORTHOSIS KWQ NUVASIVE, INC. 7739215 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR