MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO THREADED 7.5X45MM POLYAXIAL SCREW

Model Number	5119.1747
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision surgery was needed to remove a creo threaded screw due to patient infection post operatively.
Additional Manufacturer Narrative
Visual and functional inspection of the reported issue could not be conducted due to the implant not being returned by the time of the evaluation, and no additional information was provided.The observed overall risk is low, which does not exceed 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 cannot be traced.

• Brand Name: CREO
• Common Device Name: CREO THREADED 7.5X45MM POLYAXIAL SCREW
• 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: 21334695
• Report Number: 3004142400-2025-00018
• Device Sequence Number: 3772333
• Product Code: MNH
• UDI-Device Identifier: 00889095104721
• UDI-Public: 00889095104721
• 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
• Device Implanted Year: 2024
• Device Explanted 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): 02/07/2025

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: 5119.1747
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male