MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; FIXATION DEVICE, INTERNAL, SPINE, CONSTRUCT

Model Number	7146.0110
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was unavailable for evaluation.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that during a standard plif with the surgeon a tulip popped off after patient left or on (b)(6) 2025.Our last documented x-ray has tulip detached screw head on (b)(6) 2025.
Additional Manufacturer Narrative
The part was not returned for evaluation.The purpose of this investigation is to evaluate the reported issue of head pull-off.A review of the dhr and material certifications could not be completed as the lot number of the affected part is not available.A review of the available post-op x-rays confirms that the modular screw head was not connected to the screw shank.Sales rep confirms that the patient was asymptomatic, this issue was only observed in a standard post-op x-ray of the construct.As the patient had no symptoms, a revision was not performed to repair to disassembled screw.Sales rep confirms that the patient was asymptomatic, this issue was only observed in a standard post-op x-ray of the construct.As the patient had no symptoms, a revision was not performed to repair to disassembled screw.For the observed level calculation, the occurrence rate is based on the number of related complaints to the hazard divided by the total number of locking caps sold for systems within project that use a modular tulip.There is not a multiplier for this item, and the date range is the twelve months prior.As shown above, 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.The following sections were updated for this supplemental report.B4, g6, h2, h3, h6, h10.
Event or Problem Description
It was reported that during a standard plif with the surgeon a tulip popped off after patient left or on (b)(6) 2025.Our last documented x-ray has tulip detached screw head on 10 sep 2025.

• Brand Name: CREO
• Common Device Name: FIXATION DEVICE, INTERNAL, SPINE, CONSTRUCT
• 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: 23417514
• Report Number: 3004142400-2025-00271
• Device Sequence Number: 18388259
• Product Code: NKB
• UDI-Device Identifier: 00889095200874
• UDI-Public: 00889095200874
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7146.0110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 11/21/2025
• 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: Unknown