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

Model Number	5119.0542
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A revision surgery took place on (b)(6) 2026, following the patient claiming they felt a "snap" in their spine during a walk.This occurred 4 months after the original procedure that took place in (b)(6) 2025.Pre-operative images appeared as if one of the locking elements (set screws) was loosened.During the procedure, it was discovered that a second locking element was also loose, although this had not been visible on the preoperative x-ray.The screw was replaced with one of a larger diameter, and the set screws were replaced with new ones.The images suggest that the left l3 cap is disconnected from the construct.The images do not provide clarity on the status of the right l3 cap.Due to the inability to replicate operative conditions it cannot be confirmed the state of the caps upon revision.The perceived failed implants were able to be removed from the patient and were replaced accordingly.As reported, the patient experienced no post-operative complications.As reported, this failure did not result in any additional harm to the patient.The product is within the anticipated risk; therefore, the overall risk of the system has been maintained and will continue to be monitored.
Event or Problem Description
It was reported that revision surgery for scoliosis was performed due to the fact that, on x-ray imaging, one of the locking elements (set screws) appeared to be loosened.During the procedure, it was discovered that a second locking element was also loose, although this had not been visible on the preoperative x-ray.The screw was replaced with one of a larger diameter, and the set screws were replaced with new ones.The issue concerns the use of cobalt-chromium rods.As observed in the attached image, when a titanium rod is used, the set screw can be tightened deeply and sits flush with the screw head (tulip).However, when a cobalt-chromium rod is used, the set screw cannot be tightened further and remains slightly protruding above the level of the screw head.

• 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: 24911448
• Report Number: 3004142400-2026-00081
• Device Sequence Number: 9102573
• Product Code: MNH
• UDI-Device Identifier: 00889095099300
• UDI-Public: 00889095099300
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K124058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

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: 5119.0542
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/17/2026
• 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: 14 YR
• Patient Sex: Female
• Patient Weight: 51 KG
• Patient Race: White