MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. SECURE; SECURE®-C ENDPLATE & CORE ASSEMBLY, 11X12, 6MM, 6°

Model Number	714.166S
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned for evaluation.The superior endplate and inferior endplate were intact with polished bearing and with a few minor scratches.The bony apposition side showed minor loss of plasma coating and considerable bony remnants adhered to the surface.Bony material was observed inside the inserter recess slot of the inferior endplate.The secure c core was intact with minor deformation on both superior and inferior bearing surfaces.Gouge and bite marks were observed around the core with the majority on the anterior rim of the component.The inferior recess features of the core showed mild deformation.The deformation on the bearing surfaces of the core are consistent with contact of the edge of the endplate bearing surfaces.All damage features observed on the implant components are consistent with use of surgical instruments during the removal process.The stretch deformation on the core bearing surfaces are consistent with removing the core during surgery.The patient presented with pain and the alleged reason for removal was heterotopic ossification.Based on the information available, there is no indication of implant malfunction.The exact cause of the reported issue could not be determined.
Event or Problem Description
It was reported that a revision surgery was completed to remove a secure c implant.

• Brand Name: SECURE
• Common Device Name: SECURE®-C ENDPLATE & CORE ASSEMBLY, 11X12, 6MM, 6°
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 12395318
• Report Number: 3004142400-2021-00163
• Device Sequence Number: 5130873
• Product Code: MJO
• UDI-Device Identifier: 00889095179071
• UDI-Public: 00889095179071
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: D162420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• 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): 08/27/2021

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: 714.166S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR