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

Model Number	151.002
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	10/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant collapsed while implanted in patients neck.It was recognized on post op scan.The implant was removed on (b)(6) 2025 and sent for decontamination.
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 the implant collapsed while implanted in patients neck.It was recognized on post op scan.The implant was removed on (b)(6) 2025 and sent for decontamination.
Additional Manufacturer Narrative
The part was not returned.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.The following sections were updated for this supplemental report: a1, a2, a3, a6, b4, g3, g6, h2, h6, h10.

• 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: 23542101
• Report Number: 3004142400-2025-00272
• Device Sequence Number: 13182446
• Product Code: MQP
• UDI-Device Identifier: 00889095042856
• UDI-Public: 00889095042856
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K112756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 12/10/2025

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: 151.002
• Device Lot Number: BAB0CAMN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/10/2025
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Race: White