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

Model Number	1119.7090
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This investigation evaluated the reported issue of rod fracture.Visual inspection supports the reported issue.The hazard/failure that matches the identified failure discussed above from the systems risk analysis is "implant failure post-op." product is within the anticipated risk; therefore, the overall risk of the system has been maintained and will continue to be monitored.See risk reconciliation form for more details.
Event or Problem Description
It was reported that both rods were broken at l3-l4 which lead to a revision.The patient had a previous case few months ago, l2-l5 plf,plif.

• 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: 23294263
• Report Number: 3004142400-2025-00253
• Device Sequence Number: 15959436
• Product Code: MNH
• UDI-Device Identifier: 00889095064810
• UDI-Public: 00889095064810
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K124058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2025

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: 1119.7090
• Device Lot Number: BGY337EG
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown