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

Model Number	1119.7085
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the details provided, a l4-s1 posterior fusion was completed on (b)(6) 2023 with creo implants.On (b)(6) 2026, a revision surgery was completed because the patient had adjacent segment disease.During the revision surgery, it was found that the left rod was broken at the l4 level.The rod was removed, and the construct was extended to l1-s1 with creo implants.Due to the inability to replicate surgical conditions and the forces experienced post-op, the exact cause of the failure cannot be determined.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.
Event or Problem Description
It was reported that the patient underwent removal of the l4/s1 rod due to adjacent segment disease.Intraoperatively, the surgeon noticed that the rod was broken at the left l4 level.The surgeon fixed l1/s1 using creo.

• 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: 24673843
• Report Number: 3004142400-2026-00049
• Device Sequence Number: 10144914
• Product Code: MNH
• UDI-Device Identifier: 00889095064803
• UDI-Public: 00889095064803
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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: 1119.7085
• Device Lot Number: BGU076KD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 61 YR
• Patient Sex: Female