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

Model Number	7160025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent operation on (b)(6) 2025; fixation level: th10 ¿ l3: ps, l1 :x-core, l2/3 plif.The condition was an l1 burst fracture.The surgeon inserted coroent lm into the l2/l3 intervertebral space by plif and performed posterior fixation from th10 to l3.And then, the surgeon then changed the patient's position and replaced the l1 to x-core via an anterior approach.During the surgery, there was minimal bleeding and the patient's vital signs were stable.However, the patient but did not regain consciousness and exhibited occasional convulsions.Ct scans were performed from the head (including the implant site) to the abdomen, but the surgeon could not identify the cause.The patient treated in the icu while the cause is being investigated.On (b)(6), the patient had an mri scan to find the cause, and there were no findings in the blood vessels and implants.We did not obtain any comments regarding a causal relationship with our implants and medical devices from the surgeon.The surgeon suspected neurological damage due to an epileptic seizure, cerebral infarction, or pulmonary embolism, but could not identify the cause.On (b)(6): the patient showed consciousness reaction, but the level was low.On (b)(6): the patient remained conscious and took meals.There was no other adverse patient consequences reported.This event occurred in japan.
Additional Manufacturer Narrative
The device is unavailable for evaluation.The root cause cannot be determined at this time.A supplemental report will be submitted upon receipt of additional information to support this investigation.

• 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: 23933826
• Report Number: 2031966-2025-00171
• Device Sequence Number: 9527850
• Product Code: MQP
• UDI-Device Identifier: 00887517424235
• UDI-Public: 887517424235
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090176
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 7160025
• 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: 12/17/2025
• Initial 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Sex: Female