MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE HELIX REVOLUTION ACP SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	7800240
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plate and fixation screws were returned to nuvasive for evaluation and the complaint was confirmed.Examination found contact damage to the screw ports consistent with screw/washer premature contact.Additionally three of the four screws were noted to have damaged or missing lock washers and contact damage to the threads and or head of the screws consistent with improper contact to the plate.Review of the provided radiograph noted the two superior screw where not locked into the plate and the plate had pulled a few millimeters from the vertebra but still attached to the inferior vertebra.Review of the event report note the screw pull through took place during the index procedure but not recognized until postoperative radiograph review.The damage observed is consistent with excessive angulation of screw and or off centered screw placement allowing the screws/washer assembly to prematurely contacting the side of the port damaging the lock washers during placement and considered the result of an inadvertent operational error.No additional investigation required.Manufacturing review: review of the device history records of all devices notes no material non-conformances, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure.Parts met acceptance criteria upon release.Label review: "potential adverse events and complications.Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s), loss of fixation, nonunion or delayed union." "warnings, cautions and precautions.The implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient." ".Correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.These devices are not intended to be used as the sole support for the spine.While proper selection can minimize risks, the size and shape of patient anatomy may present limitations on the size of the chosen implants.The nuvasive acp system is designed to assist in providing an adequate biomechanical environment for fusion.If a delayed union or nonunion occurs the implant may fail due to metal fatigue.Patients should be fully informed of the risk of implant failure." ".Bending of the nuvasive acp system is not recommended.Bending will compromise the mechanical performance of the plate and may adversely affect fit and function of the screw retaining mechanisms.If bending is unavoidable, be certain to bend the plate between the screw holes and retaining mechanisms.Inspect the plate for damage after bending.Implant components should be handled and stored appropriately to protect them from unintentional damage.The surgeon should avoid introducing notches or scratches into the plate surfaces as these may induce premature failure of the component.Notching, striking, and/or scratching of implants with any instrument should be avoided to reduce the risk of breakage.To prevent compromising the bone-screw interface, caution should be taken not to over-torque the temporary fixation pin once it has tightened against the plate.To allow for proper utility of the locking mechanism during screw placement, use a drill-guide with the awl and/or drill to create a centered screw hole into the vertebral bodies." ".Follow proper instrument selection as specified in the surgical technique.The nuvasive acp system is designed to provide biomechanical stabilization as an adjunct to cervical fusion and should be used with anterior column support.Without anterior column support, its use may not be successful.Spinal fixation should only be undertaken after the surgeon has had hands on training in this method of spinal fixation and has become thoroughly knowledgeable about spinal anatomy and biomechanics.A surgical technique is available for instructions on the important aspects of this surgical procedure.Postoperative evaluation of the fusion and implant status is necessary.The surgeon may remove the implant once a solid fusion is obtained.The patient must be informed of the potential of this secondary surgical procedure and the associated risks.Care should be taken to ensure that all components are ideally fixated prior to closure." "patient education: 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 patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed." "pre-operative warnings 3.Care should be used in the handling and storage of the acp implants.The implants should not be scratched or damaged.Implants and instruments should be protected during storage and from corrosive environments.For sterile implants: assure highly aseptic surgical conditions, and use aseptic technique when removing the acp implant from its packaging.Inspect the implant and packaging for signs of damage, including scratched or damaged devices or damage to the sterile barrier.Do not use the acp implants if there is any evidence of damage.4.Refer to cleaning and sterilization instructions below for all non-sterile parts.5.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." "post-operative warnings during the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as to other complications.To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques." "method of use please refer to the surgical technique for this device." 9400042-en f-2023-05.
Event or Problem Description
On (b)(6) 2025 a patient underwent a three level anterior cervical discectomy fusion at c4-c6.It was reported that in a follow-up x-ray image, they detected that three upper screws came loose from the plate.No adverse patient symptoms reported.On (b)(6), 2025 a revision took place where the plate and screws were removed.No patient injury reported no additional complications noted.

• Brand Name: NUVASIVE HELIX REVOLUTION ACP SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: macy stout ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 21406845
• Report Number: 2031966-2025-00025
• Device Sequence Number: 15780812
• Product Code: KWQ
• UDI-Device Identifier: 00887517135513
• UDI-Public: 887517135513
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K093804
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7800240
• Device Lot Number: DR5396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 104 KG