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

Model Number	8975000
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
In (b)(6) 2022 a patient underwent a laminectomy and fusion procedure at c3/4 due to chin on chest and extreme kyphosis following cervical laminectomy and spondylodesis at c3/4.Approximately seven months post op the patient experienced "crackling" noises from their neck and subsequent imaging found the occipital plate had fractured at the tulip on one side of the plate and there was noted luxation of the rod connected to the tulip on the other side of the plate.On (b)(6) 2022 an anterior corpectomy was performed from c5-7 with posterior fixation installation from occiput to t4 to address extreme cervical kyphosis.
Additional Manufacturer Narrative
The product was returned and radiographs were provided and both confirmed the complaint.The patient's postoperative physical activity is unknown and it is unknown if the patient suffered a fall.No torque handle information was provided and it is unknown if hand tightening was utilized.Examination found the right connector arm separated from the housing assembly and deformed as well as fractured in half.Rod lock screws were separated from the assembly with extreme rod contact damage on the inferior side.Though no definitive root cause can not be determined the damage observed and reported time in-situ suggest excessive loading related to postoperative physical activity or incomplete final lock down resulting in postoperative loosening, toggle and subsequent fracture.A follow up report will be submitted should additional information be received.Labeling review: "potential adverse events and complications: as with any major surgical procedures, there are risks involved in orthopedic surgery.Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant components." "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.The vuepoint oct system and vuepoint ii oct system can also be linked to 3.5mm to 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.Care should be taken to insure 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: care should be used during surgical procedures to prevent damage to the devices and injury to the patient"."post-operative warnings: damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as to other complications.".

• Brand Name: NUVASIVE VUEPOINT II OCT SYSTEM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 15974094
• Report Number: 2031966-2022-00283
• Device Sequence Number: 12511851
• Product Code: NKG
• UDI-Device Identifier: 00887517954398
• UDI-Public: 887517954398
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K180198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 12/07/2022

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 Expiration Date: 02/05/2024
• Device Model Number: 8975000
• Device Lot Number: NN0724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2022
• 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: 12/06/2022
• Initial Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Female