MAUDE Adverse Event Report: NUVASIVE INC NUVASIVE COHERE CERVICAL INTERBODY SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

Model Number	4071647P2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Muscle Weakness/Atrophy (1967); Vertigo (2134); Nonunion/Delayed-union Bone Fracture (2369); Neck Pain (2433); Neck Stiffness (2434); Balance Problems (4401); Paresthesia (4421); Back pain (4895)
Date of Event	04/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report was created from a study review where no device problem was reported, the device remains in-situ so no evaluation was completed and no radiographs were provided so the complaint could not be confirmed.Review of the reported event noted a lack of relief of presurgical symptoms as well as new pain and dysfunction, radiographs reportedly identified pseudoarthrosis an instrumented level.A definitive root cause of the events could not be determined with the limited information provided although pseudoarthrosis is a complication of spinal procedure and may be the result of patient related factors, implant selection or placement, excessive loading and or postoperative excessive physical activity.No additional investigation can be completed.Labeling review: "contraindications:surgical procedures other than those listed in the indications for use section of this guide.Patients with an active local or systemic infection.Conditions which tend to retard healing such as blood supply limitations or previous infections.Insufficient quality or quantity of bone, comminuted bone surfaces or pathologic conditions such as cystic change or severe osteopenia that would impair the ability of the cohere cervical interbody fusion device to securely fixate to the bone.Patients with conditions such as mental illness, senility or alcoholism that tend to restrict his or her ability or willingness to follow postoperative instructions during the healing process." "potential adverse events and complications potential adverse effects resulting from use of the cohere cervical interbody fusion device include, but are not limited to, the following.Loss of fixation in bone.Degenerative changes or instability of segments adjacent to fused vertebral levels.Nerve damage due to surgical trauma or presence of the device.Sensitivity, allergies, or other reaction to the device material.Tissue reactions including macrophage and foreign body reactions adjacent to implants.Nonunion, delayed union or pseudoarthrosis, possibly requiring further surgery.Malalignment of anatomical structures (i.E.Loss of normal spinal contours or change in height).Pain, discomfort and abnormal sensations due to presence of the implant.Adverse effects may necessitate re-operation, revision or removal surgery.Implant removal should be followed by adequate postoperative management." "warnings, cautions and precautions.Correct selection of cohere cervical interbody fusion device components is extremely important.Carefully select the appropriate device size based on the needs of each individual patient.Over-distraction of the disc space can lead to facet over-distraction and spinous process contact.Confirm lateral fluoroscopy shows proper sagittal alignment." "patient selection information the surgeon is responsible for patient selection.The surgeon is responsible for understanding the appropriate indications and contraindications associated with the device and selecting the surgical procedures and techniques determined to be the best for each individual patient.Each surgeon must evaluate the appropriateness of the device and the procedure used to implant the device based on his/her own training experience.The physician must determine if the device is appropriate for patients having any of the following physical or emotional conditions: drug and/or alcohol and/or tobacco addiction and/or abuse.Compromised wound healing.Demonstrated psychological instability, inappropriate motivation or attitude.Unwillingness to accept the possibility of multiple surgeries for revision or replacement.Lack of understanding that their preoperative capacity may not be fully recovered even after successful implantation." 9402598-en f-01/2021.
Event or Problem Description
On (b)(6) 2023 a patient underwent an anterior cervical interbody fusion at c5/6 and c6/7 with an anterior cervical fixation plate at c5 to c7.On (b)(6) 2024 patient reported neck stiffness and low back pain that radiates into his legs on (b)(6) 2024 patient reported neck pain which radiates into his arms, balance problems, hand dysfunction and grip weakness and headaches as well as continued low back pain requiring injection.On (b)(6) 2025 patient required continuing cervical and lumbar injections to manage pain.On (b)(6) 2025 radiographs and ct images confirmed c5-6 pseudoarthrosis.On (b)(6) 2025 the patient is experiencing paresthesias and vertigo.Note vertigo was one of main pre-op sx.That was thought to have initially improvement post operatively with return ~1 year in.The patient is currently being evaluated for a revision procedure.

• Brand Name: NUVASIVE COHERE CERVICAL INTERBODY SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): NUVASIVE INC; 7475 lusk blvd.; san diego CA 92121
• Manufacturer (Section G): NUVASIVE INC.; 7475 lusk blvd.; san diego CA 92121
• Manufacturer Contact: whitney ginter ; 7475 lusk blvd.; san diego, CA 92121
• MDR Report Key: 22066445
• Report Number: 2031966-2025-00091
• Device Sequence Number: 9394420
• Product Code: ODP
• UDI-Device Identifier: 00887517056337
• UDI-Public: 887517056337
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K231735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 4071647P2
• 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: 05/15/2025
• Initial Report FDA Received Date: 05/21/2025
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Weight: 85 KG