MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; SURGICAL SCREWDRIVER, REUSABLE

Model Number	1119.0010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a creo locking cap popped out on (b)(6) 2026, a year after surgery was completed.The original date of surgery was (b)(6) 2025.
Additional Manufacturer Narrative
The purpose of this investigation is to evaluate the reported issue of a creo cap loosening.The implant was not returned, but visual inspection of the imaging provided confirmed the reported issue.Based on the information provided, a posterior spinal fusion of l5-s1 was completed on (b)(6) 2025 with creo implants.On (b)(6) 2026 it was identified that the left l5 locking cap was loose.It was confirmed that no abnormalities were experienced by the surgeon during the case.Due to the inability to investigate the implant or replicate surgical conditions, the exact cause of the failure cannot be determined.The hazard/failure that matches the identified failure discussed above from the systems risk analysis is "migration; locking cap disassembles from construct." 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.No determinations could be made as to the cause of the reported issue.

• Brand Name: CREO
• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• 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: 25535620
• Report Number: 3004142400-2026-00123
• Device Sequence Number: 21236612
• Product Code: LXH
• UDI-Device Identifier: 00889095167979
• UDI-Public: 00889095167979
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: D154976
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2026

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
• 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: 05/21/2026
• Initial Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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