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

Model Number	714.206S
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Spinal Cord Injury (2432)
Date of Event	07/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient was myelopathic and required a revision surgery to remove a secure-c endplate assembly (714.206s) and core (414.207s).
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Review of the post-operative and recent follow-up x-rays, showed the implant to be in a kyphotic position with minimal angular motion when comparing in flexion and extension.The returned device did not show any structuralor mechanical defect other than minor scratches and gouge marks that may have occurred during removal.The exact cause of the reported issue cannot be determined.

• Brand Name: SECURE-C
• Common Device Name: SECURE-C ENDPLATE ASSEMBLY, 13X14, 6 DEGREE
• 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: 18825713
• Report Number: 3004142400-2018-00030
• Device Sequence Number: 3047178
• Product Code: MJO
• UDI-Device Identifier: 00889095179101
• UDI-Public: 00889095179101
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P1000003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2024

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: 714.206S
• Device Lot Number: GBR003AJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 03/04/2024
• 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 Age: 38 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Race: White