MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. EXCELSIUS GPS; ROBOT, SURGICAL, NAVIGATION UNIT

Model Number	6143.1001
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	03/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation revealed that there was no system malfunction.It was reported the procedure for levels t3-t9 was performed using competitive hardware, where there was a reported loss of navigational integrity at t3-r.Case logs were not submitted for investigation, so no formal investigation could be performed.However, a loss of navigational integrity could be attributed to a dynamic reference base (drb).Drb shifts can lead to a loss of navigational integrity and misplaced implants.If a loss of navigational integrity is suspected to have occurred, it is recommended to perform a landmark check or verification to ensure the registration was successfully calculated.Ultimately, the user opted to abort the case after t3-r was placed, with a potential pneumothorax reported as effect to the patient.The patient was stabilized and no further effects to the patient were reported.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.The cause of the reported issue can be traced to user technique.
Event or Problem Description
It was reported that while using the excelsius gps system, this was a t3-t9 fusion with the robot using competitive hardware.Only navigated instruments were the hsb, drill, tap, and awl.A spinous process clamp was placed at t10, and sm was placed on top of the clamp.The surgeon was informed about the caveats of doing this.After the hsb and drill were used on the first trajectory on the right t3, the surgeon placed the tap at the beginning of the pilot hole and placed a k-wire down the tap without the use of any imaging.The surgeon reported that k-wire felt like it was "bouncing" and not in bone.He was concerned that navigation was inaccurate and placed the screw using a pedicle finder and c-arm for imaging.Shortly after moving to the left, t3 anesthesia reported the patient's blood pressure was dropping.The surgical team quickly closed the patient and flipped to the stretcher.After flipping onto a stretcher, anesthesia reported the patient's lung was collapsing and that she had a possible pneumothorax.A chest tube was placed, and the patient was stabilized to get her to ct for imaging.

• Brand Name: EXCELSIUS GPS
• Common Device Name: ROBOT, SURGICAL, NAVIGATION UNIT
• 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: 24872119
• Report Number: 3004142400-2026-00073
• Device Sequence Number: 10029204
• Product Code: OLO
• UDI-Device Identifier: 00889095481297
• UDI-Public: 00889095481297
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K171651
• 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): 04/14/2026

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: 6143.1001
• Device Lot Number: GPS-0595
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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