MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; 4.75MM CURVED ROD, COBALT CHROME, 40MM LENGTH

Model Number	7067.7040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was available for evaluation.It was reported that an initial surgery was completed in (b)(6) 2023 for a tlif at l4-l5 using an altera interbody spacer and creo 4.75 cocr screws and rods.A revision surgery was completed in (b)(6) 2025 to extend the construct to l5-s1 and evaluate the previous fusion at l5-s1.During the second surgery, the left rod implanted in the initial surgery was found to be fractured.It was further reported the patient appeared to have a non-union at l4-l5.The rods and screws from the original surgery at l4-l5 were then replaced with new rods and screws and the construct was extended down to s1 with an additional altera interbody spacer placed at l5-s1.Optical microscopy showed scratches evident on the surface of the rod and slight straightening of the rod, although the cause of these factors and potential relationship to the rod failure could not be ascertained.The product is within the anticipated risk; therefore, the overall risk of the system has been maintained and will continue to be monitored.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a revision was needed to replace a broken creo 4.75mm curved rod that was causing patient pain post operatively.

• Brand Name: CREO
• Common Device Name: 4.75MM CURVED ROD, COBALT CHROME, 40MM LENGTH
• 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: 21752405
• Report Number: 3004142400-2025-00071
• Device Sequence Number: 21244575
• Product Code: MNH
• UDI-Device Identifier: 00889095196191
• UDI-Public: 00889095196191
• 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: 2023
• 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): 04/01/2025

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: 7067.7040
• Device Lot Number: JNA230PD/JNA751ND
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 04/02/2025
• 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: Unknown