MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO STABILIZATION SYSTEM; TOWER REDUCER, THREADED

Model Number	6120.2000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision was needed to remove hardware due to creo screws seizing up.
Additional Manufacturer Narrative
The device was returned for evaluation; however, evaluation is anticipated.No determinations could be made as to the cause of the reported issue.

• Brand Name: CREO STABILIZATION SYSTEM
• Common Device Name: TOWER REDUCER, THREADED
• 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: 22398229
• Report Number: 3004142400-2025-00137
• Device Sequence Number: 4941332
• Product Code: LXH
• UDI-Device Identifier: 00889095173352
• UDI-Public: 00889095173352
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K124058
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/03/2025

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: 6120.2000
• Device Lot Number: TIB074EC/AHU284EB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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