MAUDE Adverse Event Report: NUVASIVE, INC. X-CORE; VERTEBRAL BODY PROSTHESIS

Model Number	7160025
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is unavailable for evaluation as it was disposed of at the hospital.The root cause cannot be determined at this time.If any additional information becomes available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during surgery the x-core 2 failed to expand.The surgeon removed it and implanted another one.This event occurred in italy.
Additional Manufacturer Narrative
The investigation revealed that after several attempts additional information regarding this event was not able to be obtained.No operative notes, or photographs were provided for review.Limited information is available outside of the reported information that ¿the core does not expand; the surgeon removed it and implanted another one and discarded the defective core.¿ the procedure was completed with the use of another cage, and no adverse effects to the patient were reported.The device was not received by manufacturer, and the complaint was unable to be confirmed.Based on the reported information, a probable cause of this failure is excessive force or user technique, which are noted precautions in the product labeling.Labeling review: warning, cautions, and precautions: ¿.Correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants.Metallic internal fixation devices cannot withstand the activity levels and/or loads equal to those placed on normal, healthy bone.These devices are not designed to withstand the unsupported stress of full weight or load bearing alone.¿ ¿.Avoid excessive distraction to decrease the risk of over distraction causing neurologic injury¿¿ ¿.To help ensure proper inserter/implant engagement, the inserter¿s-colored distal tip must face up toward the like-colored spinning sleeve of the implant.To help ensure proper anatomical alignment, the rounded corners of the x-core shape endcaps must face anterior during implant construction and placement.¿ pre-operative warnings ¿.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient¿¿ the complaint file was evaluated, and it was determined that the report relates to a nuvasive x-core 2 ti core, ø16mm 18-25mm autolock.The report indicates that the cage was not expanding when inserted.There was no patient injury associated with this reported event.Labeling, manufacturing, and risk reviews completed with no deficiencies, discrepancies or adverse trends noted.Complaint monitoring will continue, and additional action will be taken in the event that an adverse trend is identified.No additional action is planned at this time.
Event or Problem Description
It was reported that during surgery the x-core 2 failed to expand.The surgeon removed it and implanted another one.The hospital staff threw away the defective one so there will be no part returned.There were no consequences for the patient.This event occurred in italy.

• Brand Name: X-CORE
• Common Device Name: VERTEBRAL BODY PROSTHESIS
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• 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: 23457944
• Report Number: 2031966-2025-00145
• Device Sequence Number: 8961335
• Product Code: MQP
• UDI-Device Identifier: 00887517424235
• UDI-Public: 887517424235
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: IT
• PMA/510(K) Number: K090176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 12/31/2025

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: 7160025
• Device Lot Number: FM1139EC
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/31/2025
• 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