MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. FORTIFY; FORTIFY 012MM CORE, HEIGHT 25-37MM

Model Number	151.053
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a fortify i spacer collapsed post-operatively requiring revision surgery.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Evaluation of the intra-operative and follow-up imaging provided, appear to show a loss of approximately 8mm of height.It was stated that during the original surgery, the implant was removed from the patient and was repositioned.The inserter was removed and re-attached during this part of the procedure.It is possible that bone graft material or soft tissue may have been forced into the lock cavity at this time.If wedged between the lock and the lock cavity, this material may have forced the lock into an unlocked state.The exact cause of the reported issue cannot be determined.

• Brand Name: FORTIFY
• Common Device Name: FORTIFY 012MM CORE, HEIGHT 25-37MM
• 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: 18832871
• Report Number: 3004142400-2019-00008
• Device Sequence Number: 20697408
• Product Code: MQP
• UDI-Device Identifier: 00889095042917
• UDI-Public: 00889095042917
• 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: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2024

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 03/04/2024
• 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: Female