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

Model Number	151.152
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544)
Date of Event	03/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that patient was operated on for a chordoma tumor on (b)(6) 2024.In their follow up appointment on (b)(6) 2026 it was determined the cage had collapsed.In review of prior appointments, it's been determined that cage collapsed was also occurring on (b)(6) 2024.The patient will be scheduled for revision sometime in may.The part was not returned but plans on being sent back post revision.This report will be reopened when pd has the physical part to evaluate.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 the patient was operated on for a chordoma tumor on (b)(6) 2024.Then in his follow up appointment on (b)(6) 2026 it was determined the cage had collapsed.In review of prior appointments, it's been determined that cage collapsed was also occurring on (b)(6) 2024.The patient will be scheduled for revision sometime in may.

• 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: 24940786
• Report Number: 3004142400-2026-00076
• Device Sequence Number: 12168249
• Product Code: MQP
• UDI-Device Identifier: 00889095043044
• UDI-Public: 00889095043044
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K112756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 151.152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/21/2026
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Race: White