MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO STABILIZATION SYSTEM; SELF-RETAINING DRIVER SHAFT, 1/4 INCH QUICK-CONNECT

Model Number	6067.0060
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not available for evaluation.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a potential patient adverse effect had occurred involving an infection.
Event or Problem Description
It was reported that a potential patient adverse effect had occurred involving an infection.
Additional Manufacturer Narrative
The device was not available for evaluation.The reported issues of infection at the site of the original implantation that led to the revision surgery, and tip damage on driver shafts while attempting removal of locking caps during the revision surgery.No images or parts were returned or available for return for evaluation.The creo threaded locking cap part 1067.0010 was assumed to be the locking cap involved since the screws were reported to be creo threaded.The exact cause for the infection, or the difficulty in removed the locking cap cannot be determined from the available evidence.Products are 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: a2, a3, b4, g6, h6, h10.

• Brand Name: CREO STABILIZATION SYSTEM
• Common Device Name: SELF-RETAINING DRIVER SHAFT, 1/4 INCH QUICK-CONNECT
• 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: 22689826
• Report Number: 3004142400-2025-00158
• Device Sequence Number: 8268490
• Product Code: LXH
• UDI-Device Identifier: 00889095167979
• UDI-Public: 00889095167979
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: D154976
• 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,Followup
• Report Date (Section B): 08/12/2025

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: 6067.0060
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/20/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 08/12/2025
• 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 Age: 66 YR
• Patient Sex: Male