MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. FORTIFY; FORTIFY Ø12MM CORE, HEIGHT 19-25MM

Model Number	151.051
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device was unavailable for evaluation, therefore the resources used for this analysis were limited to the post-operative image, the three-month post-operative image, and the reported issue description above.Comparing the two images, the extending cylinder height on the three-month, post-operative x-ray is less in comparison to the immediate post-operative image.This is indicative of a potential collapse.No additional information is known of this issue and therefore, no determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a revision surgery was needed to replace fortify core that lost height post operatively.This event occurred in australia.
Event or Problem Description
It was reported that a revision surgery was needed to replace fortify core that lost height post operatively.This event occurred in australia.
Additional Manufacturer Narrative
The device was available for evaluation.The fortify expandable corpectomy spacer was implanted on (b)(6) 2024.Following the surgery the patient had some falls.The implant was able to expand and collapse with inserter attached.The expansion gear would not turn when manually twisted, indicating that the internal lock was engaging once again.The height loss was noticed in the three-month post-operative image showing signs of the implant losing height.No determinations could be made as to the cause of the reported issue.

• Brand Name: FORTIFY
• Common Device Name: FORTIFY Ø12MM CORE, HEIGHT 19-25MM
• 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: 19584430
• Report Number: 3004142400-2024-00119
• Device Sequence Number: 7279378
• Product Code: MQP
• UDI-Device Identifier: 00889095042894
• UDI-Public: 00889095042894
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K112756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 07/22/2024

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: 151.051
• Device Lot Number: BAB72FWP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2023
• 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 Sex: Female
• Patient Race: Asian