MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. EXCELSIUS GPS; PATIENT STABILIZATION STAND

Model Number	6143.2505
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation.The reported issue is symptomatic of a mechanical failure of the patient stabilization stand.A system malfunction was unable to be verified due to insufficient information.No adverse effect on the patient was reported.The overall risk has been maintained and no further investigation is required.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
During the final trajectory placement, the pss base began sliding despite being locked down.Base was unlocked and locked again, and it continued to move.Navigation was no longer accurate, and final trajectory was aborted.

• Brand Name: EXCELSIUS GPS
• Common Device Name: PATIENT STABILIZATION STAND
• 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: 22807236
• Report Number: 3004142400-2025-00160
• Device Sequence Number: 13027540
• Product Code: OLO
• UDI-Device Identifier: 00193982185220
• UDI-Public: 00193982185220
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K200047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2025

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: 6143.2505
• Device Lot Number: GPS-0423
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 08/14/2025
• 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