MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. EXCELSIUS; SURGICAL SCREWDRIVER, REUSABLE

Model Number	6143.2692
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a case using the 30 mm mis gps driver and while putting in screws the surgeon figured out that on the new 2 piece style gps drivers, they can slide down the array without knowing on navigation.They ended up putting in a screw further than we knew on the screen and didn't catch it till a confirmation spin of the screws.They also measured this after the case and the driver can slide 8 mm further down the tube if you accidentally hit the button in the middle of the array.
Additional Manufacturer Narrative
The device was not available for evaluation.No determination could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that during a case using the 30mm mis gps driver and while putting in screws the surgeon figured out that on the new 2 piece style gps drivers, they can slide down the array without knowing on navigation.They ended up putting in a screw further than we knew on the screen, and didn't catch it till a confirmation spin of the screws.They also measured this after the case and the driver can slide 8mm further down the tube if you accidentally hit the button in the middle of the array.
Additional Manufacturer Narrative
Visual and functional inspection of the reported issue could not be conducted due to not being returned by the time of the evaluation.The hazard/failure that matches the identified failure discussed above from the systems risk analysis is instrument end binds, breaks, or disassembles excelsius robotics system.Product is within the anticipated risk; therefore, the overall risk of the system has been maintained and will continue to be monitored.The following sections were updated for this supplemental report.B4, g6, h2, h6, h10.

• Brand Name: EXCELSIUS
• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• 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: 23294891
• Report Number: 3004142400-2025-00232
• Device Sequence Number: 4783462
• Product Code: OLO
• UDI-Device Identifier: 00193982278724
• UDI-Public: 00193982278724
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 11/11/2025

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: 6143.2692
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/11/2025
• 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