MAUDE Adverse Event Report: NUVASIVE INC. NUVASIVE X-CORE EXPANDABLE VBR SYSTEM, NUVASIVE X-CORE MINI CERVICAL EXPANDABLE; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	7180025A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Cage broke in patient and had to pull it out and use another cage.No adverse effects to patient.
Additional Manufacturer Narrative
The device was not received by nuvasive and no photographs received so the complaint could not be confirmed.Lot number provided does not match any nuvasive device nomenclature.Due to a lack of information provided a definitive root cause could not be determined although review of the reported event found it to be consistent with known failure mode where the inserter is attached and turned backwards past the starting point with force, or the core is expanded the retracted with force damaging or jamming the device and likely a cause or contributor to the reported event.No additional investigation can be completed at this time should additional information or the device be received an additional investigational report will be filed.Manufacturing review: no lot code information was provided so a complete manufacturing review could not be completed labeling review: "pre-operative warnings 5.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." "all components should be final tightened per the specifications in the surgical technique.Implants should not be tightened past the locking point, as damage to the implant may occur." "warnings, cautions and precautions the subject device is intended for use only as indicated.The implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient." ".Note: once the core is either in its fully compressed or fully expanded state, do not continue to rotate the teardrop handle.Over-expanding or over-compressing may result in implant stripping."(b)(4).

• Brand Name: NUVASIVE X-CORE EXPANDABLE VBR SYSTEM, NUVASIVE X-CORE MINI CERVICAL EXPANDABLE
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• 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: 21945799
• Report Number: 2031966-2025-00082
• Device Sequence Number: 18232377
• Product Code: MQP
• UDI-Device Identifier: 00887517365804
• UDI-Public: 887517365804
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K193506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 05/01/2025

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: 7180025A
• 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: 05/01/2025
• Initial Report FDA Received Date: 05/01/2025
• 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 Sex: Unknown