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

Model Number	LG-5L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device has been returned to nuvasive for evaluation and radiographs provided did not confirm the event.The patient bone quality was reported as good.The patient post operative physical activity is unknown.Review of the report noted it merely stated "querying osteolysis".Review of the provided radiographs noted no radiolucency, bone loss or osteolysis observed and the artificial disc appears slightly anterior noting the inferior vertebra is shadowed and not visible.Due to a lack of information provided at this time a definitive root cause could not be established however, patient selection, implant selection and placement, postoperative physical activity or patient related factors may have caused or contributed to this unconfirmed event.Should the explanted device or tissue samples be provided for evaluation additional investigation will take place at that time.Manufacturing review: review of the device history record notes no material non-conformances, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure.Parts met acceptance criteria upon release.Label review: ".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." ".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." ".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.".
Event or Problem Description
On (b)(6) 2024 the surgeon removed the simplify device from c6/7 querying osteolysis.Upon looking at the device patches of the ti coating from the endplates had delaminated from the peek body.Wound swabs were taken and sent to pathology, an acdf was performed and the explanted device will be returned for investigation.

• 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: george panfili ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 20292943
• Report Number: 2031966-2024-00246
• Device Sequence Number: 8126964
• Product Code: MJO
• UDI-Device Identifier: 00843285100115
• UDI-Public: 843285100115
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P20022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 09/24/2024

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: LG-5L
• Device Lot Number: W86377
• 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: 09/03/2024
• Initial Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2023
• 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: 38 YR
• Patient Sex: Male