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

Model Number	151.053
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor any imaging was available for evaluation.The cause of the reported issue could not yet be determined.
Event or Problem 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 or Problem 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.
Additional 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.
Additional 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 or Problem 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
• Common Device Name: FORTIFY Ø12MM CORE, HEIGHT 25-37MM
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon 19403
• MDR Report Key: 12012652
• Report Number: 3004142400-2021-00115
• Device Sequence Number: 14498153
• Product Code: MQP
• UDI-Device Identifier: 00889095042917
• UDI-Public: 00889095042917
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K112756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 151.053
• Device Lot Number: BAW026TH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 06/03/2021; 06/03/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 07/16/2021; 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other