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

Model Number	1067.4745
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Unspecified Musculoskeletal problem (4535)
Date of Event	03/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The purpose of this investigation is to evaluate the reported issue of loosening of pedicle screws post-op.An investigation into the dhr of the part cannot be completed at this time as the rep could not provide the lot numbers of the broken parts.Functional/visual inspection could not be completed as the parts were not returned.However, the sales rep was contacted by the complaints coordinator, and the rep noted that a revision case was required due to the screws loosening, which was completed successfully.The rep also noted that the patient had poor bone quality.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 on (b)(6) 2025 the patient underwent a spinal procedure using creo mis.Then on (b)(6) 2026 the revision surgery was performed due to the loosening of pedicle screws at l5.The fixation area was extended from l2 to iliac.The sale rep commented that the patient's bone quality was poor.The locking caps were obtained, but the loose mis screws were not.

• 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: 24940788
• Report Number: 3004142400-2026-00075
• Device Sequence Number: 5623764
• Product Code: MNH
• UDI-Device Identifier: 00889095023879
• UDI-Public: 00889095023879
• 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: 2025
• 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): 04/21/2026

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: 1067.4745
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/21/2026
• 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: Male
• Patient Race: Asian