MAUDE Adverse Event Report: Globus Medical, Inc. CREO; Thoracolumbosacral pedicle screw system

Model Number	7218.8190
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/04/2026
Type of Reportable Event	Malfunction

• Brand Name: CREO
• Common Device Name: Thoracolumbosacral pedicle screw system
• 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 ; +1(610)930-1800
• MDR Report Key: 50041808
• Report Number: 3004142400-2026-00151
• Device Sequence Number: 16054486
• Product Code: NKB
• UDI-Device Identifier: 00193982066680
• UDI-Public: 00193982066680
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191835
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/27/2026

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: 7218.8190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown