MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. FORTIFY; VERTEBRAL BODY PROSTHESIS

Model Number	137.300
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that fortify cage was placed into the patient in (b)(6) 2025.On 19 mar 2026 patient heard a "clunk" and the cage that was expanded had collapsed.The patient was taken back into surgery and a new fortify cage was placed.The part was returned.The rep said the inserter was used to explant the fortify core which makes this investigation indeterminate.Upon further investigation and a micro-ct scan, the "nub" of the titanium leaf spring is rounded which is causing it to not function as intended.The core can be collapsed and expanded by hand but only with a great amount of force.The dhr for the provided lot number was checked and no deviations were present.The complaint is indeterminate as the root cause of this malfunction cannot be determined from the given information.A risk reconciliation was performed and confirms that the type and frequency of this failure is captured in our latest risk analysis.
Event or Problem Description
It was reported that a fortify cage was placed into patient in (b)(6) 2025.Then on (b)(6) 2026 patient heard a "clunk" and the cage that was expanded had collapsed.The patient was taken back into surgery and a new fortify cage was placed.

• Brand Name: FORTIFY
• Common Device Name: VERTEBRAL BODY PROSTHESIS
• 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: 24940789
• Report Number: 3004142400-2026-00074
• Device Sequence Number: 20239909
• Product Code: MQP
• UDI-Device Identifier: 00889095040852
• UDI-Public: 00889095040852
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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: 137.300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/21/2026
• 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