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

Model Number	7160063
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been received for evaluation.The root cause cannot be determined at this time.A supplemental report will be submitted upon receipt of additional information.
Event or Problem Description
It was reported that the expansion mechanism with green crown appears damaged.The inserter will not expand implant and had to substitute with different cage.
Event or Problem Description
The expansion mechanism with green crown appears damaged.The inserter will not expand implant.Had to substitute with different cage.The patient may have had intra-operative injury but not directly linked to lack of expansion capability.
Additional Manufacturer Narrative
The investigation revealed a report that an x-core implant would not expand due to damage to the collar of the implant.The rep reported observing physical damage to the green expansion collar that mates with the inserter.The inserter would not expand the implant once it was attached.The surgeon removed the cage and replaced it with a different cage.There was no other adverse patient consequences directly related to this incident.The rep was unable to provide any further information or photographs of the reported event.The device was not returned for evaluation.Therefore, the lot number is unknown, and the product was not available to be reviewed by pd.Dhr review was not possible due to missing lot number.Review of the associated risk determined the hazards associated with the reported event were previously addressed.The severity and rate of occurrence documented in this reported event do not exceed the post-mitigated severity and failure mode probability estimated in the risk management file.Following review, no new risks were identified.Labeling, manufacturing, complaint history, and risk reviews were completed with no deficiencies, discrepancies, or adverse trends identified.The device was unavailable for evaluation, and the event will be used for trend data.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.

• 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: 24523981
• Report Number: 2031966-2026-00038
• Device Sequence Number: 9691625
• Product Code: MQP
• UDI-Device Identifier: 00887517424273
• UDI-Public: 887517424273
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K090176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2026

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: 7160063
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/06/2026
• 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