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

Model Number	1119.0100
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The purpose of this investigation is to evaluate the reported issue of: rod migration.Visual inspection found that locking caps have uneven indentations on the inferior surface where the caps meet the rods.Additionally, there was abrasion visible on the rod consistent with the reported migration event.The wear seen on the locking caps indicates that the rods were not properly aligned with the tulips after final tightening.Abrasive wear along the rod indicates that the rod migrated through the tulip, which is also consistent with improper rod alignment after final tightening.This wear can indicate insufficient locking, hyper lordotic rods, excessive reduction force, or hyper angulated tulips; however, the cause of this event cannot be determined as surgical conditions cannot be replicated.
Event or Problem Description
It was reported rods moved 2 months post instrumentation.The rods migrated cranially until they were completely displaced from the l5 screws.The surgeon chose to perform a revision surgery the week of (b)(6) 2026 to remove the hardware.

• 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: 25487078
• Report Number: 3004142400-2026-00132
• Device Sequence Number: 13253244
• Product Code: MNH
• UDI-Device Identifier: 00889095059649
• UDI-Public: 00889095059649
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K124058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 06/12/2026

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?: No
• Device Model Number: 1119.0100
• Device Lot Number: BA1401YL, BA140CDL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White