MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO FENESTRATED SCREW SYSTEM; CREO FENESTRATED 7.5 X 45MM MODULAR SCREW

Model Number	1192.1745
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation.Based on the evaluation and available information, the failure/hazard most closely aligns with "implant subsidence or implant migration".The failure was within the expected risk profile; therefore, no further actions will be taken at this time.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that during a revision surgery, to creo screws were found to be loose and replaced.This event occurred in austria.
Additional Manufacturer Narrative
The device was not available for evaluation as it was discarded by the hospital.Based on the evaluation and available information, the failure/hazard most closely aligns with implant subsidence or implant migration.This evaluation determined that this failure was within the expected risk profile; therefore, no further actions will be taken at this time.No determinations can be made for the cause of the reported issue.The following sections have been updated for this supplemental report: b4; b5; g6; h2; h10.
Event or Problem Description
It was reported that during a revision surgery, two creo screws were found to be loose and replaced.This event occurred in austria.

• Brand Name: CREO FENESTRATED SCREW SYSTEM
• Common Device Name: CREO FENESTRATED 7.5 X 45MM MODULAR 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: 21937701
• Report Number: 3004142400-2025-00105
• Device Sequence Number: 7985209
• Product Code: NKB
• UDI-Device Identifier: 00889095542875
• UDI-Public: 00889095542875
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K172269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 05/29/2025

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: 1192.1745
• Device Lot Number: GBC147PB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 05/29/2025
• 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: Female