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

Model Number 151.053

Device Problem Collapse (1099)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/03/2021

Event Type  malfunction  

Manufacturer Narrative

Neither the device nor any imaging was available for evaluation.The cause of the reported issue could not yet be determined.

Event Description

It was reported by a representative from the uk that a revision surgery was done for a fortify cage that collapsed post-operatively, causing adverse effects.

Event Description

It was reported by a representative from the uk that a revision surgery was done for a fortify cage that collapsed post-operatively, causing adverse effects.

Manufacturer Narrative

The device was returned for evaluation.A micro ct scan revealed nothing out of the ordinary except for excessive wear on the gear tooth at the point of contact with the locking gear.However, an exact cause of the reported issue cannot be determined.

Manufacturer Narrative

Additional information provided that the surgeon inserted the screws into c3, the implant moved at c6 resulting in the surgeon not placing screws in the inferior endplate.Imaging provided showed a loss of height in the core of 3 threads or approximately 4.5mm.The cause of the reported issue could not yet be determined.The following sections were updated: b4, b6, g6, h6 and h10.

Event Description

It was reported by a representative from the uk that a revision surgery was done for a fortify cage that collapsed post-operatively, causing adverse effects.

• Brand Name: FORTIFY
• Type of Device: FORTIFY Ø12MM CORE, HEIGHT 25-37MM
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 12012652
• MDR Text Key: 260715904
• Report Number: 3004142400-2021-00115
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 00889095042917
• UDI-Public: 00889095042917
• Combination Product (y/n): N
• PMA/PMN Number: K112756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 09/10/2021

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
• Device Operator: Health Professional
• Device Model Number: 151.053
• Device Lot Number: BAW026TH
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/03/2021
• Initial Date FDA Received: 06/16/2021
• Supplement Dates Manufacturer Received: 06/03/2021; 06/03/2021
• Supplement Dates FDA Received: 07/16/2021; 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other