MAUDE Adverse Event Report: Globus Medical, Inc. CREO; Trans-facet-screw internal spinal fixation system, sterile

Model Number	7218.8111
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026 it was found that the two screws implanted on both sides of the s2ai had fractured immediately below their heads.On (b)(6) 2026 a revision surgery was performed.The fractured screws could not be explanted and were consequently retained in the patient.
Additional Manufacturer Narrative
On (b)(6) 2026, surgery was performed and two s2ai screws were implanted.On (b)(6) 2026, it was found that the two screws implanted on both sides had fractured immediately below the head of the screw shank.On (b)(6) 2026, a revision surgery was performed, however, the fractured screws could not be explanted and are retain within the patient.The surgeon inserted screws into the sai and connected the rods using a competitor's connector.The implants that remained in the patient is made from medical grade tav (astm f136-13) and cocr (astm f1537) which are biocompatible materials.The product is within the anticipated risk; therefore, the overall risk of the system has been maintained and will continue to be monitored.No determinations could be made as to the cause of the reported issue.

• 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 ; +1(610)930-1800
• MDR Report Key: 50201313
• Report Number: 3004142400-2026-00168
• Device Sequence Number: 10366161
• Product Code: NKB
• UDI-Device Identifier: 00193982066314
• UDI-Public: 00193982066314
• 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: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/16/2026

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: 7218.8111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 08/11/2026
• 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 Age: 57 YR
• Patient Sex: Female
• Patient Race: Asian