MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. FORTIFY; FORTIFY Ø12MM CORE

Model Number	151.052
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a fortify core has lost height 3 months post operatively.
Additional Manufacturer Narrative
The device was not available for evaluation as it remains in the patient.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.
Additional Manufacturer Narrative
The device was returned for evaluation.Initial observation shows tissue is inside of the inserter hole touching the lock.The imaging provided shows tissue inside of the inserter hole.It's possible that the tissue may have caused the lock to move to the unlocked position.However, an exact cause of the reported issue could not be determined.The following sections have been updated: b4, d9, g6, h2, h3, h4, h6, h10.

• Brand Name: FORTIFY
• Common Device Name: FORTIFY Ø12MM CORE
• 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: 15320274
• Report Number: 3004142400-2022-00126
• Device Sequence Number: 14753390
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2022

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: BAY586BN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2021
• 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: Male