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

Model Number	4071427P2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Pain (1994); Neck Pain (2433); Paresthesia (4421)
Date of Event	03/20/2024
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 pain as well as dysphagia and paresthesia requiring physical therapy and narcotics for dysphagia and pain management that has continued through the one year follow up.Although no definitive root cause could not be determined with the limited information provided dysphagia is a known complication of cervical spine surgery and may be the result of patient related factors, implant selection or placement and or surgical trauma.No additional investigation can be completed.Labeling review: "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.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.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." "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
The event was identified during a review of the cervical interbody pmcf study, the report identified that on mar 05, 2024 a patient underwent a three level anterior cervical discectomy fusion at c4/5, c5/6 and c6/7 with anterior fixation c4-c7.On mar 20, 2024 the patient presented with recurrent skull pain equal in severity as prior to surgery.She also reports mild but residual base of neck and shoulder pain as well as persistent dysphagia causing weight loss.On june 03, 2024 the patient continues to have dysphagia and was referred to ent for evaluation for underlying esophageal issues.On sept 04, 2024 the patient reported continued dysphagia, left trap/shoulder and neck pain as well as paresthesia.Started physical therapy and narcotics for dysphagia and pain management for cervical pain.On mar 24, 2025 the patient reported with no change in situation and continuing with medications for pain management.

• 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: 22078702
• Report Number: 2031966-2025-00092
• Device Sequence Number: 12939385
• Product Code: ODP
• UDI-Device Identifier: 00887517056320
• UDI-Public: 887517056320
• 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: 2024
• 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): 05/23/2025

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: 4071427P2
• 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: 05/14/2025
• Initial Report FDA Received Date: 05/23/2025
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 49 KG