MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. FORTIFY; FORTIFY CORE

Device Problem Collapse (1099)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The device was not available for evaluation as it remains in the patient.Imaging provided shows the implant expanded approximately 4-5mm at the time of surgery, and no expansion 4 months post-operatively.There are no plans for a revision surgery.The exact cause of the reported issue could not be determined.

Event Description

It was reported by a representative from germany that a fortify implant collapsed 4 months post operatively.

• Brand Name: FORTIFY
• Type of Device: FORTIFY CORE
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon 19403 ; 6109301800
• MDR Report Key: 11734278
• MDR Text Key: 249966506
• Report Number: 3004142400-2021-00054
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/26/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other