MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. SECURE-C; E(?U !=.-F ENDPLATE & CORE ASSEMBLY, 11X12, 6MM, 6°

Model Number	714.166S
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the secure-c core had disassociated from the endplates approximately two months post-operatively requiring revision surgery.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Review of the 13-day post-operative and follow-up x-rays, showed the implant to have no space between the secure-c endplates.However, the core was present and was removed during the revision surgery.The returned device did not show any structural or mechanical defect other than minor scratches and some material deformation on the core at the posterior portion which may have occurred during removal.The exact cause of the reported issue cannot be determined.

• Brand Name: SECURE-C
• Common Device Name: E(?U !=.-F ENDPLATE & CORE ASSEMBLY, 11X12, 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: 18832642
• Report Number: 3004142400-2018-00067
• Device Sequence Number: 7132765
• Product Code: MJO
• UDI-Device Identifier: 00889095179071
• UDI-Public: 00889095179071
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• 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): 03/04/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 714.166S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (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: 37 YR
• Patient Sex: Female
• Patient Race: White