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

Model Number	137.001
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the reason for revision was that after the first surgery (during a control ct scan), it was found that fortify i changed height in patient's body and the screws had become loose.The aim of the revision was to remove fortify i and replace it with xpand + extend.I.This event took place in poland.
Additional Manufacturer Narrative
The device was unavailable for evaluation.No determinations could be made as to the cause of the reported issue.

• 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: 25102236
• Report Number: 3004142400-2026-00101
• Device Sequence Number: 18639534
• Product Code: MQP
• UDI-Device Identifier: 00889095040777
• UDI-Public: 00889095040777
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K121107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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: 137.001
• Device Lot Number: BAY421LE
• 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: 04/21/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 05/20/2026
• 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: 71 YR
• Patient Sex: Female