MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. FORTIFY; FORTIFY Ø12MM CORE, HEIGHT 21-29MM

Model Number	151.052
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.The device was subjected to a micro-ct scan showing that the lock has not been deformed and remains in the locked position.The inserter hole that exposes the lock was also visually confirmed as not having any soft tissue or biomaterial buildup.A series of internal measurements were taken to verify the relative dimensions were within tolerance.All inspected dimensions, except for the lock wall to center axis distance and the gear's retaining ring inner ø, are considered within tolerance.Since these values were measured from a 3d model generated by a micro-ct scan, there is to be some expected variability in the results.Having the lock wall to center axis distance and the gear's retaining ring inner ø be out of tolerance is likely not the cause for the cage's collapse.The lock wall distance being over the tolerance makes it more difficult for the lock to slip out of place, and the retaining ring's inner ø is not undersized to the point that it will counteract this increased wall distance.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a revision was needed to replace a fortify core that had lost height post operatively.

• Brand Name: FORTIFY
• Common Device Name: FORTIFY Ø12MM CORE, HEIGHT 21-29MM
• 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: 16197040
• Report Number: 3004142400-2023-00010
• Device Sequence Number: 5273597
• Product Code: MQP
• UDI-Device Identifier: 00889095042900
• UDI-Public: 00889095042900
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/17/2023

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: 151.052
• Device Lot Number: BAA403BP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 01/18/2023
• 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 Age: 64 YR
• Patient Sex: Female
• Patient Race: White