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

Model Number	5709424P2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	11/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The devices were ex-planted and sent directly to a third party lab for evaluation and the investigation is underway once completed a follow up report will be filed in an attempt to identify the root cause.Label review: "contraindications simplify® cervical artificial disc should not be implanted in patients with the following conditions: an active systemic infection or an infection at the operative site.Osteoporosis or osteopenia defined as dexa bone mineral density t-score less than -1.5.Known allergy to the implant materials (peek, ceramic, titanium)." "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 lead 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." "precautions the safety and effectiveness of the simplify® cervical artificial disc has not been established in patients with the following conditions: previous surgery at the level to be treated, more than one neck surgery via anterior approach, axial neck pain as the solitary symptom, history of an endocrine or metabolic disorder (e.G., paget¿s disease) known to affect bone and mineral metabolism, current or extended use (>6 months) of any drug that may interfere with bony/soft tissue healing, insulin-dependent diabetes, renal disease, auto-immune diseases" "preoperative: in order to minimize the risk of atraumatic periprosthetic vertebral fractures, surgeons must consider all co-morbidities, past and present medications, previous treatments, etc.Upon reviewing all relevant information, the surgeon must determine whether a bone density (dexa) scan is prudent.If dexa is performed, the patient should not receive the device if the dexa bone mineral density t-score is <-1.5, as the patient may be osteoporotic or osteopenic.Patient selection is extremely important.In selecting patients for a total disc replacement, the following factors can be of extreme importance to the success of the procedure: the patient¿s occupation or activity level; a condition of senility, mental illness, alcoholism or drug abuse; certain degenerative diseases that may be so advanced at the time of implantation that the expected useful life of the device is substantially decreased, and medical conditions that may affect postoperative management, such as alzheimer¿s disease and emphysema.The patient should be informed of the potential adverse effects (risks/complications) contained in this insert (see safety results / aes).Information on the proper implant site preparation, implant size selection, and the use of surgical instrumentation for the simplify® cervical artificial disc is provided in the surgical technique guide and should be reviewed prior to surgery.Preoperative planning may be used to estimate the required implant size and to assure that the appropriate range of sizes is available for surgery.Correct selection of the appropriate implant sizes is extremely important to assure the placement and function of the disc.The procedure should not take place if the appropriate range of sizes are not available." "intraoperative: use aseptic technique when removing simplify®cervical artificial disc from the innermost packaging.Carefully inspect each device and its packaging for any signs of damage, including damage to the sterile barrier.Do not use the simplify® cervical artificial disc if the packaging is damaged or if the implant shows signs of damage.Ensure simplify® cervical artificial disc does not come into contact with hard objects that may damage the implant and render the implant functionally unreliable.Visual inspection of the prosthesis is recommended prior to implanting the device.If any part of the device appears damaged or not fully assembled, do not use.Take care not to over-distract the disc space.Excessive removal of endplate cortical bone may result in sub-optimal outcomes." "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." "risks specific to cervical artificial discs, including the simplify cervical artificial disc, are but may not be limited to: osteolysis, bone loss, or bone resorption." 32226-e-2023-03.
Event or Problem Description
On (b)(6) 2022 a patient underwent a two-level cervical total disc replacement (ctdr) at c4/5 and c5/6 to treat mild stenosis.On (b)(6) 2024 a revision took place due to signs of osteolysis.C5/6.

• Brand Name: SIMPLIFY CERVICAL ARTIFICIAL DISC
• Common Device Name: PROSTHESIS INTERVERTEBRAL DISC
• 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: 20880748
• Report Number: 2031966-2024-00331
• Device Sequence Number: 21001552
• Product Code: MJO
• UDI-Device Identifier: 00195377105455
• UDI-Public: 195377105455
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P200022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/09/2024

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: 5709424P2
• Was Device Available for Evaluation?: Yes
• 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: 11/19/2024
• Initial Report FDA Received Date: 12/09/2024
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 88 KG