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	Spinal Column Injury (2081)
Date of Event	04/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation revealed that there was no system malfunction.It was reported that the l5-r implant was misplaced superior and lateral several times during an intra-operative procedure.An investigation into the case logs revealed the root cause was a combination of the implant plan placement and excessive deflection forces, or skiving during navigation.The l5-r implant was planned in a high-skive area causing it to deviate from the trajectory.The software correctly detected and alerted the user of high deflection forces present on the load cell during bone work, likely due to skiving that was detected while a tool is inserted into the end effector.Additionally, the globus medical representative reported lateral skiving on both navigated attempts and force meter warnings on at least one of the attempts.Ultimately, the user opted to replace the misplaced implant once using traditional methods and again using a navigated approach, and with no adverse effects to the patient reported.This evaluation has been completed via associated case logs and there are no associated work order or part returns.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 the surgeon had placed drb on right side with lpqs, and sm on left which was activated with verification probe.A spin was completed with e3d, and moved over to the robot.The surgeons then planned screws at l5 and s1 bilaterally.Wiltse approach was performed on both sides.The left side l5 and s1 screws went in with no issues.On right l5, surgeon went down with hsb then tap, tap started skiving laterally.The surgeon took the tap out, we resettled on trajectory and surgeon tried tap again same issue occurred.At this point it was decided to adjust plan, after screw was adjusted back to navigation.The surgeon used high speed burr then tap, it was still skiving, at this point it was suggested to use the pilot drill.The pilot drill was used then tap, surgeon was retracting with army navy.The pilot drill looked good on navigation, then tap was used and it seemed to follow previous trajectory.The surgeon then proceeded with screw, we were getting high force on robot as he was putting it in.We did get a check mark for screw placed.The right s1 was then put in with no issues.The e3d was brought in for fluruo shots to confirm screw placement.The ap and laterals confirmed that right l5 screw had done cephalad to plan and the tip of screw was in l4 disc space.The screw was then removed, surgeon then decided to not use navigation to put the screw back.Once right l5 screw was placed, fluro shots were taken again.The screw was right against the endplate still, surgeon wanted to do a spin and use it for navigation.A new case was created, and the scan was preformed.The surgeon planned screw very medial, in a new trajectory different to previous plans.The surgeon was concerned with size of pedicle so screw was downsized to 5.5 diameter.Once ee was on trajectory, surgeon used high speed burr, then tap, tap was going laterally.The pilot drill was used then tap.The screw was then placed to plan.Post flouro shots the screw still looked cephalad to plan, which surgeon questioned.

• 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: 25058106
• Report Number: 3004142400-2026-00084
• Device Sequence Number: 13099850
• Product Code: OLO
• UDI-Device Identifier: 00889095481297
• UDI-Public: 00889095481297
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/01/2026

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-0615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 05/01/2026
• 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