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

Model Number	SM-4
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022 a patient underwent a total disk replacement at c5/6.After a follow-up appointment on (b)(6) 2023 it was reported that there was loosening of the implant and the patient's pre-op symptoms were not relieved.A removal surgery is scheduled for (b)(6) 2023.
Additional Manufacturer Narrative
No product was returned as it still in-situ, but images provided confirmed the complaint.The patient's bone quality and postoperative physical activity are unknown.Review of the provided radiographs identified subsidence of the implant into the adjacent cranial and caudal bodies though no root cause can be determined, implant selection, bone quality, and excessive postoperative physical activity are likely causes or contributors.No device malfunction was identified.No additional investigation can be completed at this time.Should more information become available an additional record will be filed.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 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.".".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."."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.".".Anterior cervical surgery risks: anterior cervical surgical risks are, but may not be limited to: unresolved pain.".".Cervical artificial disc risks: risks specific to cervical artificial discs, including the simplify cervical artificial disc, are but may not be limited to: device subsidence." h3: device still in-situ.

• 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: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 16862379
• Report Number: 2031966-2023-00095
• Device Sequence Number: 5421124
• Product Code: MJO
• UDI-Device Identifier: 00843285100009
• UDI-Public: 843285100009
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P200022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 05/03/2023

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 Expiration Date: 02/28/2025
• Device Model Number: SM-4
• Device Lot Number: 4164
• 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: 04/10/2023
• Initial Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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 Sex: Prefer Not To Disclose