MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. EXCELSIUS3D; PORTABLE GENERAL-PURPOSE FLUOROSCOPIC X-RAY SYSTEM, DIGITAL

Model Number	6161.1000
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgery using the excelsius 3d it gave "excelsius 3d error code 17 x ray generator error." they went to do a spin for si fusion and this code popped up.They also got the following messages; "system is unable to acquire image due to the following reasons: reason #1: x-ray generator error.If problem persists for more than 1 min, reset x-ray on the settings page.If the problem continues, contact service.Reason # 2: the x-ray generator is not ready.System is attempting to remedy.If unfixed, reset x-ray in settings.Contact service if the problem persists.Reason #3: the x-ray generator has experienced the following errors): error 17: fillament system.System is attempting to clear.If unfixed, reset x-ray in settings.Contact service if the problem persists." they had to cancel the surgery due to these messages, the patient was already under anesthesia.
Additional Manufacturer Narrative
It was reported to globus medical that after the patient was under anesthesia, the case was canceled due to generator 17 errors.This evaluation has been associated with a field service work order.Any applicable parts will be returning to the methuen imaging, navigation & robotics (inr) site, and be processed there.The work order states that there were multiple issues identified on the system.The x-ray tube failed with error code 17, the filter ladder was non-operable due to a failed collimator, and a detector panel error was also present.The field service engineer was able to replace the x-ray tube, collimator board, and the panel detector fiber-optic cable.All required calibrations were completed and the system is now fully functional.There were no reported adverse effects to the patient.The severity observed did not exceed the anticipated severity.The observed overall risk level is low, which matches the observed anticipated risk level; therefore, the overall risk of the system has been maintained and there is no further investigation required.

• Brand Name: EXCELSIUS3D
• Common Device Name: PORTABLE GENERAL-PURPOSE FLUOROSCOPIC X-RAY SYSTEM, DIGITAL
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; 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: 24251345
• Report Number: 3004142400-2026-00029
• Device Sequence Number: 20910297
• Product Code: OWB
• UDI-Device Identifier: 00193982184506
• UDI-Public: 00193982184506
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K210912
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2026

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: 6161.1000
• Device Lot Number: E3D-0165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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