BEUDAMED
    FDA Adverse Event Other Summary report: N

    HELIX-REVOLUTION ACP SYSTEM

    MDR report key: 3890139 · Received June 13, 2014

    Report

    Report Number
    2031966-2014-00039
    Event Type
    Other
    Date Received
    June 13, 2014
    Date of Event
    May 14, 2014
    Report Date
    June 12, 2014
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K093804
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NUVASIVE REF: (B)(4). RADIOGRAPH CONFIRMED THE REPORTED EVENT. RETURNED DEVICES WERE MEASURED AND MET DESIGN REQUIREMENTS. RETURNED DEVICES WERE EVALUATED. REVIEW OF THE DEVICE HISTORY RECORDS NOTES NO MATERIAL NON-CONFORMANCES OR MANUFACTURING ERRORS THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS MODE OF FAILURE. PARTS MET ACCEPTANCE CRITERIA UPON RELEASE. PT ACTIVITY AT THE TIME OR PRIOR TO THE EVENT IS UNK. PT'S BONE QUALITY IS UNK. IT IS UNK IF THE PT COMPLIED WITH POST-OP CARE INSTRUCTIONS OR SUSTAINED AN IMPACT OF SOME SORT. THE PARTIAL CORPECTOMY ONLY ALLOWED 4 OR THE 8 POINTS OF FIXATION TO BE UTILIZED. THIS LIMED FIXATION MAY BE A CONTRIBUTING FACTOR. THE ANGULATION OF THE SUPERIOR SCREW MAY ALSO BE A FACTOR. THE ROOT CAUSE OF THE ISSUE REMAINS UNK.

    Description of Event or Problem · 1

    ON (B)(6) 2014, IT WAS REPORTED THAT THE RIGHT SUPERIOR CERVICAL BONE SCREW BACKED OUT OF A THREE LEVEL (C3-C6) ACDF PLATE AT C3. THE PLATE AND SCREWS WERE REMOVED AND REPLACED. REVISION ALSO INCLUDED SUPPLEMENTAL POSTERIOR FIXATION FROM C3-C7. PT IS REPORTEDLY DOING WELL POST REVISION. THE INITIAL SURGERY OCCURRED (B)(6) 2014 IN WHICH SUPPLEMENTAL CERVICAL PLATING WAS PLACED OVER A CERVICAL VERTEBRAL BODY REPLACEMENT DEVICE. THE PARTIAL CORPECTOMY SURGERY OF C4 AND C5 VERTEBRAL BODIES ONLY ALLOWED FOR FIXATION SCREWS TO BE PLACED C3 AND C6 ANTERIORLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350365 HELIX-REVOLUTION ACP SYSTEM SPINAL INT VERT BODY FIXATION APPLIANCE KWQ NUVASIVE, INC. 7801115 M23385

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention