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

Model Number	1119.0010
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The purpose of this investigation is to evaluate the reported issue of cap loosening.Visual and functional inspection was unable to be completed because the part was not returned and no images were provided.Based on the details provided, a t8-pelvis posterior fusion was completed on an unknown date with creo implants.On (b)(6) 2025, a revision surgery was completed because the locking cap came out of the iliac bolt that was connected to an accessory rod.The two primary rods were also fractured.During the revision surgery, the primary rods were replaced, the loosened locking cap was replaced, 4 screws were replaced with larger diameter screws, and 3 interbody cages were implanted.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 surgeon revised a t8-pelvis on (b)(6) 2025 in which a set cap came out of the iliac bolt that was connected to an accessory rod.The main rods of the construct fractured and a revision was required.The surgeon added 3 tlifs during the revision and replaced the main rods and accessory rods.He also upsized 4x screws of the original construct due to haloing of the bone around the screws.

• 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: 24865829
• Report Number: 3004142400-2026-00065
• Device Sequence Number: 9239034
• Product Code: MNH
• UDI-Device Identifier: 00889095059496
• UDI-Public: 00889095059496
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K124058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 04/13/2026

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: 1119.0010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 04/13/2026
• 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 Sex: Unknown