MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE VUEPOINT II OCT SYSTEM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	8980700P3
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Date of Event	07/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device was received for evaluation and no photographs were provided for review.Further, no operative notes and/or radiograph images were provided for review of usage/technique.Based on the information obtained, the complaint was unable to be confirmed and a root cause was unable to to be determined; however, the reported event may have been the result of insufficient torque on lock screws during final tightening, insufficient reduction or normalization, or possible patient activity.Labeling 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)." ".Warnings, cautions and precautions: correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.The vuepoint oct system and vuepoint ii oct system can also be linked to 3.5mm¿6.25mm rods of posterior pedicle screw and rod systems via the rod to rod connectors or transition rods.While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of the implants.Metallic internal fixation devices cannot withstand the activity levels and/or loads equal to those placed on normal, healthy bone.These devices are not designed to withstand the unsupported stress of full weight or load bearing alone."rod-to-rod connectors must be used when connecting two separate constructs.Do not use vuepoint ii extra rod connectors as the mechanical strength is not adequate for stable fixation of two separate constructs." ".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." ".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.".
Event or Problem Description
On (b)(6) 2024 a patient underwent a posterior cervical spinal fusion procedure from c2 to t3.During the procedure the implanted construct was connected to an existing thoraco-sacral construct using a transition rod and rod-to-rod connectors.On an unknown date, the patient developed post-operative dysphagia and a revision procedure was scheduled.On (b)(6) 2024, during the revision procedure, the rod-to-rod connector on the left c7 was found to have separated from the transition rod.No additional patient impact was reported.

• Brand Name: NUVASIVE VUEPOINT II OCT SYSTEM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• 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: patrick yrigoyen ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 20050756
• Report Number: 2031966-2024-00204
• Device Sequence Number: 12756735
• Product Code: NKG
• UDI-Device Identifier: 00887517001092
• UDI-Public: 887517001092
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 08/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8980700P3
• Was Device Available for Evaluation?: No
• 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: 07/31/2024
• Initial Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown