MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE SIMPLIFY DISC; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	LG-5
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The artificial disc was returned to nuvasive for evaluation where no damage, wear or dysfunction was observed.No issues were found with the returned device.Review of the provided radiographs noted the disc was well placed anterior / posteriorly as well as laterally and appears to be properly sized.Review of the reported complaint noted when the patient awoke from the procedure, they reportedly heard a noise when turning head, no noted pain or disfunction was reported.The root cause of the reported joint noise during articulation is unknown however, review of similar cases are noted to have resolved over time without revision or treatment and suspected to be the result of a lack of fluid egress back into the treated disc space allowing the core and plates to rub and likely the cause or contributor to the reported event.No additional investigation is required.Labeling review: "warnings simplify® cervical artificial disc should only be used by surgeons who are experienced with anterior cervical spinal procedures and have undergone hands-on training in the use of this device.Only surgeons who are familiar with simplify cervical artificial disc components, instruments, procedure, clinical applications, biomechanics, adverse events (aes), and risks associated with simplify® cervical artificial disc should use this device.A lack of adequate experience and/or training may led to a higher incidence of aes, including neurological complications.Correct selection of the appropriate implant size and correct placement of simplify® cervical artificial disc are essential to ensure proper performance and functioning of the device.Information regarding implant size selection and correct implant placement is provided in the simplify® cervical artificial disc surgical technique guide." "postoperative: patients should be instructed in postoperative care procedures and should be advised of the importance of adhering to these procedures for successful treatment with the device.Heavy lifting (greater than 20lbs) should be avoided for 6 weeks, and impact sports should be avoided for 3 months.Potential adverse effects of device on health below is a list of the potential adverse effects (e.G., complications) identified from the simplify cervical artificial disc clinical study results, approved device labeling for other cervical total disc replacement devices, and published scientific literature including: (1) those associated with any general surgical procedure; (2) those associated with anterior cervical spine surgery; and (3) those associated with a cervical artificial disc device, including the simplify cervical artificial disc.In addition to the risks listed below, there is also the risk that surgery may not be effective in relieving symptoms or may cause worsening of symptoms.Additional surgery may be required to correct some of the adverse effects.(table 12 including joint noise) ¿" "following completion of the procedure, patients should receive a postoperative treatment care protocol.Patients will be permitted to ambulate on the day of surgery, as tolerated, and, at the discretion of the surgeon, may wear a collar to support the neck (philadelphia, aspen, miami j, 2 poster-orthosis, etc.) until the soft tissues of the neck have healed.".
Event or Problem Description
On (b)(6) 2025 a patient underwent an cervical total disc replacement (ctdr) at c6/7 due to stenosis.After the procedure, the patient reported that the disc made a noise when moving their head/spine.On (b)(6) 2025 a revision procedure took place wherein the artificial disc at c6/7 was removed and replaced with a new one.After re-implantation of the replacement prosthesis no noise or cervical discomfort was observed.

• Brand Name: NUVASIVE SIMPLIFY DISC
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• 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: macy stout ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 21585645
• Report Number: 2031966-2025-00039
• Device Sequence Number: 8868068
• Product Code: MJO
• UDI-Device Identifier: 00843285100108
• UDI-Public: 843285100108
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P200022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 03/12/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/21/2026
• Device Model Number: LG-5
• Device Lot Number: W82547R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2025
• 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: 02/11/2025
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2022
• 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: 40 YR
• Patient Sex: Male
• Patient Weight: 98 KG