MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. FORTIFY; FORTIFY Ø12MM CORE, HEIGHT 16-20MM, 3.5°, NO SPIKES

Model Number	151.003
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was unavailable for evaluation.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a revision surgery occurred to remove a fortify cage that collapsed.
Additional Manufacturer Narrative
Related report number: mw5175317 this implant was not available for evaluation; therefore, the resources used for this analysis were limited to the written documentation of the incident received by the complaints team.The medwatch report stated that the patient had c3/4 anterior discectomy, c4/5 vertebrectomy, c5/6 discectomy and c6/7 discectomy and fusion.A later x-ray demonstrated that the corpectomy cage had lost height.A ct scan confirmed the cage had lost height.On (b)(6) 2025 the patient underwent an anterior cervical hardware revision, and posterior c2-t2 cervical fusion.The fortify cage that had reported to lose height was not returned for further evaluation into the root cause of the issue.Therefore, the lot number and any further information on the implant cannot be determined.Additionally, no xray or ct images of the implant were provided for further evaluation.The cause of the reported implant height loss cannot be determined.The complaint is deemed indeterminate.A risk reconciliation was performed and confirms that the type and frequency of this failure is captured in our latest risk analysis.The following sections were updated for this supplemental report: b4, e1, e2, e3, e4, g3, g6, h2, h6, h10.
Event or Problem Description
It was reported that a revision surgery occurred to remove a fortify cage that collapsed.

• Brand Name: FORTIFY
• Common Device Name: FORTIFY Ø12MM CORE, HEIGHT 16-20MM, 3.5°, NO SPIKES
• 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: 23213409
• Report Number: 3004142400-2025-00247
• Device Sequence Number: 15708007
• Product Code: MQP
• UDI-Device Identifier: 00889095042863
• UDI-Public: 00889095042863
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K112756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 151.003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 10/30/2025
• 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 Sex: Female
• Patient Weight: 67 KG
• Patient Ethnicity: Non Hispanic