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

Model Number	151.053
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a fortify spacer has lost height post-operatively.This event occurred in switzerland. .
Additional Manufacturer Narrative
The device was unavailable for evaluation.The resources used for this analysis were limited to the post-operative image.The post-operative shows signs of collapse.No additional information is known of this issue and therefore, no determinations could be made as to the cause of the reported issue.
Additional Manufacturer Narrative
The device was available for evaluation.The fortify cage had been returned in a plastic container since it was returned uncleaned.Once received, the device was sent to a micro-ct scan to be evaluated.The images provided from the scan show that the inserter hole that exposes the lock was visually confirmed to not have any bio-material build up.Bio-material was found in between the lock and the posterior wall.This does not point to the biologic being the cause of the locking failure since having material in that location would make it harder to unlock the implant.The engagement feature on the lock showed that its corners have been rounded off.This radius is larger towards the top of the lock compared to the bottom.The corners of the internal gear also have signs of wear.The combination of these findings is the likely failure of the lock.The expansion gear would turn when manually twisted, indicating that the internal lock was not engaged.A clicking sound was observed and most likely came from the lock skipping into the next gear tooth.The complaint is deemed indeterminate and the part is to be held for mdr file.A risk reconciliation was performed and confirms that the type and frequency of this failure is captured in our latest risk analysis.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that revision was needed to replace a fortify spacer that lost height post-operatively.This event occurred in switzerland.

• 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: 20031313
• Report Number: 3004142400-2024-00189
• Device Sequence Number: 6395387
• 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): 09/25/2024

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: 151.053
• Device Lot Number: BAY689BN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown