MAUDE Adverse Event Report: NUVASIVE, INC. X-CORE; DEVICE STERILIZATION/DISINFECTION CONTAINER, REUSABLE

Model Number	XCORE18
Medical Device Problem Codes	Structural Problem (2506); Unintended Movement (3026)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a x-core cage had been found collapsed post-operatively.
Additional Manufacturer Narrative
The device has not returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.

• Brand Name: X-CORE
• Common Device Name: DEVICE STERILIZATION/DISINFECTION CONTAINER, REUSABLE
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; 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: 22926621
• Report Number: 2031966-2025-00115
• Device Sequence Number: 9162770
• Product Code: KCT
• UDI-Device Identifier: 00887517525840
• UDI-Public: 887517525840
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/26/2026

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: XCORE18
• 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: 08/05/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 05/26/2026
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male