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

Model Number	5708914P2
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a simplify cage migrated post operatively.
Additional Manufacturer Narrative
The device was unavailable for evaluation.No determinations could be made as to the cause of the reported issue.

• Brand Name: SIMPLIFY CERVICAL ARTIFICIAL DISC
• Common Device Name: PROSTHESIS INTERVERTEBRAL DISC
• Manufacturer (Section D): NUVASIVE, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 22883179
• Report Number: 2031966-2025-00106
• Device Sequence Number: 9640687
• Product Code: MJO
• UDI-Device Identifier: 00195377105400
• UDI-Public: 195377105400
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P200022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2025

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 Model Number: 5708914P2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown