BEUDAMED
    FDA Adverse Event Other Summary report: N

    HELIX REVOLUTION ACP SYSTEM

    MDR report key: 2159556 · Received July 1, 2011

    Report

    Report Number
    2031966-2011-00029
    Event Type
    Other
    Date Received
    July 1, 2011
    Report Date
    June 30, 2011
    Manufacturer
    NUVASIVE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K093804
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT COMPLIANCE WITH EXPECTED POST-OPERATIVE CARE MAY HAVE BEEN A PROBLEM. THE EXPLANTED CONSTRUCT HAS BEEN RETAINED BY THE USER FACILITY PENDING COMPLETION OF THEIR INVESTIGATION. NO ROOT CAUSE HAS YET BEEN IDENTIFIED. FOLLOWING USER FACILITY INVESTIGATION, AND POSSIBLE FURTHER EVALUATION BY NUVASIVE, ADDITIONAL RELEVANT INFORMATION WILL BE INCLUDED IN A SUBSEQUENT REPORT. REVIEW OF LABELING NOTES THAT: "PREOPERATIVE INSTRUCTIONS TO THE PATIENT ARE ESSENTIAL. THE PATIENT SHOULD BE MADE AWARE OF THE LIMITATIONS OF THE IMPLANT AND POTENTIAL RISKS OF THE SURGERY. THE PATIENT SHOULD BE INSTRUCTED TO LIMIT POSTOPERATIVE ACTIVITY, AS THIS WILL REDUCE THE RISK OF BENT, BROKEN OR LOOSE IMPLANT COMPONENTS." "...THE PHYSICIAN/SURGEON SHOULD CONSIDER THE LEVELS OF IMPLANTATION, PATIENT WEIGHT, PATIENT ACTIVITY LEVEL, OTHER PATIENT CONDITIONS, ETC, WHICH MAY IMPACT THE PERFORMANCE OF THE SYSTEM."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN A 3-LEVEL ACDF SURGERY THAT OCCURRED (B)(6) 2011, THE HELIX REVOLUTION SCREWS SEPARATED FROM THE VERTEBRAL BODIES IN 6 OF 8 SCREWS PLACED. ALL SCREWS APPEAR TO HAVE BEEN LOCKED DOWN WHEN VIEWED IN A LATERAL CERVICAL RADIOGRAPH. REVISION SURGERY OCCURRED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HELIX REVOLUTION ACP SYSTEM SPINAL INT VERT BODY FIXATION ORTHOSIS KWQ NUVASIVE, INC. 7800362 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention