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

Model Number	6940429
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was unavailable for evaluation.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that the tip of a xlif pituitary broke off during surgery.
Additional Manufacturer Narrative
The investigation revealed a report that a small nuvasive xlif pituitary tip broke off and the surgery could proceed without any problems.There was no report of adverse patient, user, or procedure impact.No additional information is available.Specified regulatory reporting has been completed.The device was not returned to nuvasive, and no photographs were provided so the complaint could not be confirmed.The root cause of the issue is unknown, although review of the event and similarly reported events suggests this is the consequence of repetitive use, excessive off angled forces related to surgical technique.These devices are part of loaner sets that are subjected to handling and repeated sterilization cycles after distribution into the field.Wear and damage can accumulate over time.Labeling, risk, manufacturing, risk and trend 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
The tip broke off.Surgery was able to continue on without any problems.

• 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: 22882747
• Report Number: 2031966-2025-00100
• Device Sequence Number: 8861157
• Product Code: LXH
• UDI-Device Identifier: 00887517452764
• UDI-Public: 887517452764
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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: 6940429
• 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: 05/30/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 04/16/2026
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown