MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. FORTIFY; FORTIFY 12MM CORE, HEIGHT 18-23MM

Model Number	151.050S
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device was unavailable for evaluation, no additional information is known of this issue and therefore, no determinations couldbe made as to the cause of the reported issue.
Event or Problem Description
It was reported that two fortify implants were unable to expand after assembly and the surgeon had to abort the procedure.
Event or Problem Description
It was reported that two fortify implants were unable to expand after assembly and the surgeon had to abort the procedure.
Additional Manufacturer Narrative
Two fortify cores with matching lot numbers were inspected visually, with uct scanning, and found in one specimen that the expanding cylinder attached to the top endplate had rotated out of position and collided into and broke a thin member inside the core of the implant.In the second specimen, the same thin member is broken and binding the expansion gear and expanding cylinder.The expanding cylinder of the second specimen does not appear rotated out of position.It was reported that the implants were "expanded 2-3 threads for assembly".Visual inspection shows that the cores were fully expanded when assembled, which is incorrect per the technique guide that states "visually inspect the extending cylinder to confirm that the first one to two threads are visible on the superior side of the gear before assembly".The incorrect assembly technique described may have presented a situation where the internal components of the core shifted during assembly of the endplates and broke the cores.The exact circumstances surrounding this event cannot be replicated.The complaint is indeterminate.The following sections were updated for this supplemental report: b4, e1, e2, e3, g3, g6, h3, h6, h10.

• Brand Name: FORTIFY
• Common Device Name: FORTIFY 12MM CORE, HEIGHT 18-23MM
• 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: 23100891
• Report Number: 3004142400-2025-00224
• Device Sequence Number: 15798447
• Product Code: MQP
• UDI-Device Identifier: 00889095615838
• UDI-Public: 00889095615838
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K162315
• 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: Physician
• 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: 151.050S
• Device Lot Number: GBC325AE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/01/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/30/2025
• 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 Sex: Unknown