MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; CREO MIS LOCKING CAP

Model Number	1134.0010
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The part was returned for evaluation and images were provided.The images confirm the locking cap was not captured within the tulip, as well as showed evidence of the screw being outside of the pedicle.It cannot be determined if the screw had migrated or was misplaced due to lack of initial images.Upon evaluation of the returned locking cap, the wear marks typical with final tightening were not seen on the cap.Due to the inability to replicate surgical conditions, the exact cause of the failure cannot be determined.Product is within the anticipated risk; therefore, the overall risk of the system has been maintained and will continue to be monitored.
Event or Problem Description
It was reported that a revision surgery occurred due to a creo mis locking cap and screw backing out.This event occurred in japan.

• Brand Name: CREO
• Common Device Name: CREO MIS LOCKING CAP
• 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: 22939423
• Report Number: 3004142400-2025-00179
• Device Sequence Number: 9800964
• Product Code: MNH
• UDI-Device Identifier: 00889095071139
• UDI-Public: 00889095071139
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K124058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2025

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: 1134.0010
• Device Lot Number: BAC3BFEC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 09/02/2025
• 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 Sex: Female
• Patient Race: Asian