MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; FIXATION DEVICE, INTERNAL, SPINE, CONSTRUCT

Model Number	1134.0010
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
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 the patient came in for a post op visit and the surgeon noticed the creo locking cap had released from the tulip head.
Event or Problem Description
It was reported that the patient came in for a post operation visit and the surgeon noticed the creo locking cap had released from the tulip head.
Additional Manufacturer Narrative
The part was not returned for evaluation.The purpose of this investigation is to evaluate the reported issue of cap loosening.Visual inspection of the imaging was not provided before the due date of the complaint.Supplemental information may be added if the imaging is returned.Based on the information provided, a posterior spinal fusion procedure from l4-l5 was completed.After the surgery during routine checkup, it was seen that a locking cap at l5 was loose.There was a revision surgery where the locking cap was replaced with no issues.The surgical sales representative was contacted for more information, and their response confirmed no abnormalities were experienced by the veteran creo mis surgeon user in either procedure.Due to the inability the implant or replicate surgical conditions, the exact cause of the failure cannot be determined.The hazard/failure that matches the identified failure discussed above from the systems risk analysis is "implant breakage/disassembly post-op.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.The following sections were updated for this supplemental report: b4, g6, h2, h6, h10.

• Brand Name: CREO
• Common Device Name: FIXATION DEVICE, INTERNAL, SPINE, CONSTRUCT
• 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: 23392127
• Report Number: 3004142400-2025-00262
• Device Sequence Number: 15965676
• Product Code: MNH
• UDI-Device Identifier: 00889095071139
• UDI-Public: 00889095071139
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K124058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 11/20/2025

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: 1134.0010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/04/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/20/2025
• 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: Unknown