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

Model Number	5709424P2
Medical Device Problem Code	Implant subsidence (4078)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On an unknown date a patient underwent a cervical total disc replacement (ctdr).During the 3 month follow up the surgeon noted post operative subsidence at the index level.No revision is planned and the patient will continue to be monitored.
Additional Manufacturer Narrative
No device was available for evaluation as the implant remains in-situ.The radiographs provided were reviewed and the reported subsidence was able to be confirmed as the inferior face of the implant appeared to have subsided into the vertebral body, which also caused the superior face to rotate anteriorly.Information regarding the patient's bone quality/bone density was not provided for review.A review of manufacturing records was unable to be performed as the part and lot information of the product involved in the event was not available.Based on the information obtained, a definitive root cause was unable to be determined; however, subsidence may be related to possible patient related factors (such as bone quality), implant selection and sizing, or endplate preparation.Labeling review: "¿contraindications: simplify cervical artificial disc should not be implanted in patients with the following conditions: osteoporosis or osteopenia defined as dexa bone mineral density t-score less than -1.5." ".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." ".Preoperative: in order to minimize the risk of atraumatic periprosthetic vertebral fractures, surgeons must consider all comorbidities, 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." ".Intraoperative: 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." ".Cervical artificial disc risks: risks specific to cervical artificial discs, including the simplify cervical artificial disc, are but may not be limited to: device migration, device subsidence.Excessive device height loss.Disc space collapse.Additional surgery due to loss of fixation, infection or injury.Removal, revision, reoperation or supplemental fixation of the disc." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: 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: 21638886
• Report Number: 2031966-2025-00043
• Device Sequence Number: 18249258
• 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
• 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): 02/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5709424P2
• 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: 02/17/2025
• Initial Report FDA Received Date: 03/18/2025
• 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
• Patient Age: 40 YR
• Patient Sex: Female