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

Model Number	7067.7055
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The purpose of this investigation is to evaluate the reported issue of rod breakage.After a review of related complaints, each rod fracture incident occurred with parts from various lots, manufactured at various times, and manufactured by two separate vendors.Given this random assortment of failures, it is unlikely that the occurrence of this risk can be linked to any manufacturing defect.Inspection of the fractured rod is not possible as no explants have been returned to globus from this incident, and no imaging is available to confirm the reported issue.The sales representative was unable to be contacted after 3 attempts.Without additional information and considering that surgical conditions cannot be replicated outside the operating room, the cause of this failure is unknown.
Event or Problem Description
The patient had an l4-s1 interbody fusion with the creo 4.75 screw system on (b)(6) 2023.The patient returned to the surgeon in late 2025 for pain.Surgeon determined the patient had adjacent level disease at l3-4 and possibly an immature fusion from the previous surgery at l4-s1.The patient was scheduled for an l3-4 posterior interbody fusion, which was done on (b)(6) 2026.During the surgery on (b)(6) it was determined that one of the previously placed 4.75 cobalt chrome rods was broken, and the patient had not fully healed/fused from the original surgery.

• 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: 24270694
• Report Number: 3004142400-2026-00017
• Device Sequence Number: 21513665
• Product Code: KWQ
• UDI-Device Identifier: 00889095196221
• UDI-Public: 00889095196221
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K124058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 02/05/2026

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: 7067.7055
• Device Lot Number: JNS328DB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Male