MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; TRANS-FACET-SCREW INTERNAL SPINAL FIXATION SYSTEM, STERILE

Model Number	1067.4645
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was needed to replace a misplaced creo mis screw that was causing the patient discomfort/pain.This event occured in singapore.
Additional Manufacturer Narrative
The purpose of this investigation is to evaluate the reported issue of a misplaced screw.Visual and functional inspection was unable to be completed because the part was not returned, and no imaging was provided.Based on the details provided, a l4-s1 mis tlif was completed in 2021 with creo mis screws.The left l4 6.5x45mm creo amp screw was misplaced and was causing the patient pain and discomfort.A revision surgery was completed on (b)(6) 2025 to remove and replace the left l4 screw.The calculated observed risk level matches the expected risk level; therefore, the overall risk of the system has been maintained and there is no further investigation required.

• Brand Name: CREO
• Common Device Name: TRANS-FACET-SCREW INTERNAL SPINAL FIXATION SYSTEM, STERILE
• 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: 24121623
• Report Number: 3004142400-2026-00003
• Device Sequence Number: 9598936
• Product Code: MNH
• UDI-Device Identifier: 00889095023688
• UDI-Public: 00889095023688
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K124058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/20/2026

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: 1067.4645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 01/20/2026
• 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