MAUDE Adverse Event Report: NUVASIVE, INC. XLIF; EXTERNAL SPINAL FIXATION SYSTEM

Model Number	6914424
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the planned surgery was spinal cage insertion via l-lif (crestline) between l2/l3/l4 vertebrae and posterior decompression of th10/th12, severe arterial bleeding occurred because the cobb slipped forward during dissection of the intervertebral disc between l2/l3.The surgeon attempted to stop the bleeding by applying pressure using gauze and a hemostatic agent, but this was difficult to achieve, so a blood transfusion was administered.The hemostasis was unsuccessful, and the patient was transferred to another hospital.At the new hospital, the cardiovascular surgeon performed emergency surgery on the same day and successfully stopped the bleeding by inserting a stent.
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.

• Brand Name: XLIF
• Common Device Name: EXTERNAL SPINAL FIXATION SYSTEM
• 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: 23989287
• Report Number: 2031966-2026-00004
• Device Sequence Number: 18772548
• Product Code: LXH
• UDI-Device Identifier: 00887517392190
• UDI-Public: 887517392190
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 6914424
• Device Lot Number: FD7366803
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Weight: 75 KG