MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; ORTHOPAEDIC ROD REDUCER

Model Number	6120.5000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/18/2025
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 on (b)(6) 2025, surgery was performed to extend the fixation area for the patient with l5/s posteriorly fixed by creo due to infection.The surgeon tried to remove the locking cap on the right s suing a driver, but it would not come off.As a result, four drivers were used, but all of which broke off.One of these drivers left a broken piece inside the locking cap.The broken piece could not be removed and remains in the locking cap.The surgeon inserted screws into the sai and connected the rods using a competitor's connector.

• Brand Name: CREO
• Common Device Name: ORTHOPAEDIC ROD REDUCER
• 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: 24802193
• Report Number: 3004142400-2026-00082
• Device Sequence Number: 9944693
• Product Code: LXH
• UDI-Device Identifier: 00889095173604
• UDI-Public: 00889095173604
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6120.5000
• Device Lot Number: FMW071BB
• 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: 08/28/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 05/13/2026
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male