MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; 4.75MM CURVED ROD, COBALT CHROME, 60MM LENGTH

Model Number	7067.7060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a revision for previous extension, a creo 4.75mm curved rod was found broken in two places and was replaced.
Additional Manufacturer Narrative
The part has not been reviewed for evaluation.The cause of the reported issue cannot be traced at this time.
Additional Manufacturer Narrative
The device was available for evaluation.It was reported that an initial surgery was completed on 5/31/22 for a posterior interbody fusion at l3-l5 with creo 4.75 cocr screws and rods.A revision surgery was completed on 01/13/25 to extend the construct to l2-l3 for adjacent level symptoms.During the second surgery, one of the rods implanted in the initial surgery was found to be fractured in two places.The rods and screws from the original surgery were then replaced with additional screws placed at l1-l2.X-ray images of the original construct showed one of the rods fractured at l3-l4.It could not be determined if the rods were bent prior to implantation.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 during a revision for previous extension, a creo 4.75mm curved rod was found broken in two places and was replaced. .

• Brand Name: CREO
• Common Device Name: 4.75MM CURVED ROD, COBALT CHROME, 60MM 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: 21355695
• Report Number: 3004142400-2025-00022
• Device Sequence Number: 9003117
• Product Code: MNH
• UDI-Device Identifier: 00889095196238
• UDI-Public: 00889095196238
• 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: 2022
• 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,Followup
• Report Date (Section B): 03/11/2025

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: 7067.7060
• Device Lot Number: JNY297SD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2025
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/11/2025
• 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