MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO; 5.5MM CURVED ROD, TITANIUM ALLOY, 50MM LENGTH

Model Number	1119.7050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a revision was needed to replace creo curved rods that were found broken post operatively.The investigation is still ongoing.Nothing could be determined as to the cause of the reported issue.
Event or Problem Description
It was reported that a revision was needed to replace creo curved rods that were found broken post operatively.This event occurred in spain.
Event or Problem Description
It was reported that a revision was needed to replace creo curved rods that were found broken post operatively.This event occurred in spain.
Additional Manufacturer Narrative
The device was not available for evaluation.The issue reported was of a double rod fracture within a l4/l5 fixation construct.The initial surgery was conducted on (b)(6) 2023.Post-op x-rays of the lumbar spine (ap and lateral, taken on (b)(6) 2023) were provided showing the construct intact with no fractures.It should be noted that a l1/l2 grade 1 spondylolisthesis is present, with a collapsed disc causing excessive osteophytic growth to develop on the anterior and posterior edges of the endplates.This type of pathology, in addition to the lack of boney on-growth of native patient anatomy to the implants, can greatly increase the forces transferred to the construct.Furthermore, a revision surgery to remove the fractured rods was conducted during the month of (b)(6) 2024 (specific day not provided).A video stepping through a coronal ct scan (taken on (b)(6) 2024) was provided.Upon evaluation of the video, both rods were visibly fractured.The fractures on the rods were located where the l5 screw heads meet the rods, leaving larger rod portions attached to the l4 screw heads and smaller portions attached to the l5 screw heads.The l4 screw head/rod portions were oriented toward the right of the midsagittal plane, and the orientation of the l5 screw head/rod portions pointing inward toward the midsagittal plane.It should be noted that when comparing the x-ray and ct images, the l5 screw heads can be seen having relatively maintained their implanted positions after rod failure.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.

• Brand Name: CREO
• Common Device Name: 5.5MM CURVED ROD, TITANIUM ALLOY, 50MM 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: 21171859
• Report Number: 3004142400-2025-00014
• Device Sequence Number: 19917414
• Product Code: MNH
• UDI-Device Identifier: 00889095064735
• UDI-Public: 00889095064735
• 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
• 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): 04/30/2025

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: 1119.7050
• Device Lot Number: BGA187HG/BGY335RG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/31/2024
• Supplement Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2022
• 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