MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. SECURE C; SECURE-C ENDPLATE & CORE ASSEMBLY, 13X14, 6MM, 6

Model Number	714.266S
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Both the endplates and the core were returned for evaluation.Initial observation shows deformation on the core's anterior face as well as on one side.The anterior face of the inferior endplate had deformation as well.The deformation observed could be from the use of surgical instruments to remove the device.Further observation shows the inferior and superior endplates had bony remnants on the bony apposition side.The bearing surfaces on both the superior and inferior endplates did not appear to have any markings or signs of deformation.The patient was treated with secure-c at c7-t1.It is important to note that secure-c is only indicated for use from c3 to c7.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a revision surgery was completed to remove a secure c implant.

• Brand Name: SECURE C
• Common Device Name: SECURE-C ENDPLATE & CORE ASSEMBLY, 13X14, 6MM, 6
• 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: 15657273
• Report Number: 3004142400-2022-00151
• Device Sequence Number: 15047177
• Product Code: MJO
• UDI-Device Identifier: 00889095179118
• UDI-Public: 00889095179118
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 10/14/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: 714.266S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2018
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 165 KG