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	Insufficient Information (4580)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a revision was needed to replace a creo rod was 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 a creo rod was found broken 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: 21171906
• Report Number: 3004142400-2025-00004
• Device Sequence Number: 9494235
• 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 Explanted Year: 2024
• 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): 01/16/2025

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: JNA417AD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2022
• 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: Required Intervention; Other
• Patient Sex: Unknown