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	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision surgery was needed due to creo mis locking caps backing out.This event occurred in japan.
Additional Manufacturer Narrative
Two creo mis locking caps were received for evaluation, both from the same lot.Reinspection of the returned locking caps confirmed dimensional and functional conformance.Both locking caps lacked wear signs in the center of the underside of the locking caps.The position and extent of the wear marks present on these locking caps suggests one or multiple of the following conclusions: final tightening at l3 was not completed or did not reach the recommended 8 nm of torque.Final tightening was not completed during a "relaxed" state of the construct, which did not allow the rod to normalize onto the locking cap resulting in uneven loading of the construct and therefore, final tightening was completed according to the recommended technique, though extreme curvatures of the rod at the region of l3 prevented the locking cap from appropriately normalizing resulting in uneven loading of the rod onto the locking cap.Any of the above conclusions could result in premature loosening of the locking cap within the tulip.A definitive cause cannot be established.Should additional information be made available, a secondary evaluation will be conducted and supplemental information provided.Product is within the anticipated risk; therefore, the overall risk of the system has been maintained and will continue to be monitored.See risk reconciliation form for more details.

• 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: 22939535
• Report Number: 3004142400-2025-00192
• Device Sequence Number: 9676760
• 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: BAC3E4MC
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/12/2025
• 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): 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: Male
• Patient Race: Asian