BEUDAMED
    FDA Adverse Event Other Summary report: N

    HELIX-REVOLUTION ACP SYSTEM

    MDR report key: 3929811 · Received June 26, 2014

    Report

    Report Number
    2031966-2014-00043
    Event Type
    Other
    Date Received
    June 26, 2014
    Date of Event
    April 1, 2014
    Report Date
    June 25, 2014
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K093804
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RADIOGRAPH CONFIRMED THE REPORTED EVENT. THE BONE SCREW APPEARS TO HAVE BACKED OUT APPROXIMATELY 5 MM. REVISION OCCURRED TO REMOVE AND REPLACE THE PLATE AND SCREWS. THE DEVICES WERE NOT RETURNED AND NO FURTHER EVALUATION OF THE PRODUCT CAN BE COMPLETED AT THIS TIME. PATIENT ACTIVITY AT THE TIME OR PRIOR TO THE EVENT IS UNKNOWN. PATIENT'S BONE QUALITY IS UNKNOWN. IT IS UNKNOWN IF THE PATIENT COMPLIED WITH POST-OPERATIVE CARE INSTRUCTIONS OR SUSTAINED AN IMPACT OF SOME SORT. THE ROOT CAUSE OF THE ISSUE REMAINS UNKNOWN. REVIEW OF LABELING NOTES.

    Description of Event or Problem · 1

    ON (B)(6) 2014, IT WAS REPORTED THAT THE INFERIOR CERVICAL BONE SCREW BACKED OUT OF A ACDF PLATE AT C7. PATIENT WAS ASYMPTOMATIC. THE PLATE AND SCREWS WERE REMOVED AND REPLACED. PATIENT IS REPORTEDLY DOING WELL POST REVISION. THE INITIAL ACDF SURGERY OCCURRED (B)(6) 2014 IN WHICH A THREE LEVEL (C4-C7) CERVICAL PLATE WAS PLACED OVER THREE PEEK INTERBODY SPACERS. VOL REF# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373199 HELIX-REVOLUTION ACP SYSTEM SPINAL INT VERT BODY FIXATION APPLIANCE KWQ NUVASIVE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention