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

Model Number	1175.1554
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a revision surgery for broken rods.During the revision the tip of driver broke while removing set screw/locking cap.No pieces were left in patient.
Additional Manufacturer Narrative
The device was unavailable for evaluation.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that there was a revision surgery for broken rods.During the revision the tip of driver broke while removing set screw/locking cap.No pieces were left in patient.
Additional Manufacturer Narrative
Inspection of the instrument could not be completed as the driver was not returned.There were no images returned to confirm the incident.Due to timing of the complaint, the sales representative could not be contacted for additional information.Supplemental information may be added should the part/more information be returned.The observed risk level is within expected risk.The following sections were updated for this supplemental report: b4, g2, g6, h2, h6, h10.

• 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: 24377544
• Report Number: 3004142400-2026-00025
• Device Sequence Number: 11980579
• Product Code: NKB
• UDI-Device Identifier: 00889095482300
• UDI-Public: 00889095482300
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K180210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1175.1554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 03/16/2026
• 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 Age: 77 YR
• Patient Sex: Female
• Patient Race: White