MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. FORTIFY; FORTIFY 12MM CORE, HEIGHT 21-29MM

Model Number	151.052
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device was not returned for evaluation making a complete evaluation impossible.The three day post-operative images provided show the lower endplate clearly detached from the core and a subsidence in both the superior and inferior vertebral endplates.No immediate post-operative images were provided to verify that the fortify construct was correctly assembled.No determinations can be made as to the exact cause of the reported issue.The following sections have been updated for this supplemental report: b4, e1, h2, h6, h10.
Event or Problem Description
It was reported that the fortify inferior endplate of the cage dislodged from the core post-operatively requiring revision surgery.

• Brand Name: FORTIFY
• Common Device Name: FORTIFY 12MM CORE, HEIGHT 21-29MM
• 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: 18809734
• Report Number: 3004142400-2019-00051
• Device Sequence Number: 17953999
• Product Code: MQP
• UDI-Device Identifier: 00889095042900
• UDI-Public: 00889095042900
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K112756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• 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): 02/28/2024

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: 151.052
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 73 YR
• Patient Sex: Male
• Patient Race: White