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	Pulmonary Embolism (1498); Adult Respiratory Distress Syndrome (1696); Thrombosis/Thrombus (4440)
Date of Event	10/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The event was identified during a review of the cervical interbody pmcf study, the report identified that on (b)(6) 2024 a patient underwent a three level anterior cervical discectomy fusion (acdf) procedure at c3/4, c4/5 and c5/6.On (b)(6) 2024 the patient presented to the er with shortness of breath and was diagnosed with 2 pulmonary embolisms and deep vein thrombosis (dvt).He was admitted and treated and sent to a rehabilitation facility.Six weeks post op post operative the patient has reportedly recovered but still on medication.
Additional Manufacturer Narrative
No device malfunction was alleged and the devices remain in-situ so no complaint confirmation could be made.Review of the reported event identified 10 days postoperative the patient presented with shortness of breath and diagnosed with 2 pulmonary embolisms as well as a deep vein thrombosis that are considered unrelated to nuvasive devices but a commonly known complication of surgical procedure.The patient had to be hospitalized but has now recovered.The root cause appears to be the result of patient related factors and surgical trauma.No additional investigation required.Manufacturing review: no lot code information was provided so a complete manufacturing review could not be completed.Although review of ncmr records and similar events notes no non-conformance with respect to material type, treatments or dimensions that may have caused or contributed to this mode of failure.Labeling review: "contraindications surgical procedures other than those listed in the indications for use section of this guide.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.Patients with foreign body sensitivity, suspected or documented material allergy or intolerance.Where material sensitivity is suspected, appropriate tests should be conducted and sensitivity rules out prior to implantation." "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.Pain, discomfort and abnormal sensations due to presence of the implant.Hematoma or thrombosis." "warnings, cautions and precautions the cohere cervical interbody fusion device should be used only by those physicians who have been trained in the appropriate, specialized procedures.Knowledge of appropriate surgical techniques, instrumentation, proper selection and placement of implants and postoperative patient care and management are essential to a successful outcome.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." "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." "information to obtain a surgical technique manual or should any information regarding the products or their uses be required, please contact your local representative or nuvasive directly at." (b)(4).

• 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: 21151595
• Report Number: 2031966-2025-00011
• Device Sequence Number: 9134602
• Product Code: ODP
• UDI-Device Identifier: 00887517056337
• UDI-Public: 887517056337
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 01/14/2025

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: 01/09/2025
• Initial Report FDA Received Date: 01/14/2025
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male