MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. FORTIFY; FORTIFY Ø12MM CORE, HEIGHT 25-37MM

Model Number 151.053

Device Problems Collapse (1099); Mechanical Problem (1384)

Patient Problem Fall (1848)

Event Date 08/02/2021

Event Type  malfunction  

Manufacturer Narrative

Additional information provided that the patient fell post-operatively.Imaging provided after the patient fell showed that the implant and anterior plate dislodged.The device was returned for evaluation and it was observed that the features and components of the implant showed wear on the lock tooth and locking gear.The exact cause of the reported issue could not be determined.

Event Description

It was reported that a revision surgery was completed to remove a fortify cage that collapsed post operatively.

• Brand Name: FORTIFY
• Type of Device: FORTIFY Ø12MM CORE, HEIGHT 25-37MM
• 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: 12395517
• MDR Text Key: 271126341
• Report Number: 3004142400-2021-00157
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 00889095042917
• UDI-Public: 00889095042917
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D140943
• 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: 08/30/2021

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
• Device Model Number: 151.053
• Device Lot Number: BAX726VK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 08/31/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2020
• 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
• Patient Age: 54 YR