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

Model Number	1119.0010
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The purpose of this investigation is to assess the reported issue involving a slipped rod and a loosened locking cap.A visual and functional evaluation could not be performed because the affected components were not returned, and no imaging was provided.According to the report a ct scan confirmed a slipped rod at s1.A revision procedure was subsequently performed to extend the previous fusion to the pelvis.During the revision, the screw from which the rod had slipped was found with the locking cap still fully engaged within the tulip.Because the affected components were not returned, we are unable to determine whether the locking cap loosened and caused the rod to slip, or if the rod slipped first and subsequently resulted in the locking cap becoming loose.The calculated observed risk level aligns with the expected risk level.Therefore, the system risk remains acceptable, and no further investigation is required.The following sections were updated for this supplemental report: b4, e1, g3, g6, h2, h6, h10.
Event or Problem Description
It was reported that the creo screw head somehow separated from the construct, resulting in a revision surgery extension of a previous fusion.
Event or Problem Description
It was reported that the creo screw head somehow separated from the construct, resulting in a revision surgery extension of a previous fusion.
Additional Manufacturer Narrative
The device was not available for evaluation.No determinations could be made as to the cause of the reported issue.

• 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: 24121618
• Report Number: 3004142400-2026-00014
• Device Sequence Number: 9371437
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2026

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
• 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: 01/04/2026
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 01/23/2026
• 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 Sex: Unknown