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	01/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.The device is not available for evaluation as it remains in the patient.Review of the imaging taken in the initial surgery show that the core was expanded approximately 1-2mm.The post-operative imaging show no measurable gap of expansion visible.This indicates that the implant appears to have contracted by the majority of the height it was originally expanded.As the device is not available for evaluation, no determinations for the loss of height can be made.
Event or Problem Description
It was reported that a fortify spacer lost height post-operatively.

• 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: 18821417
• Report Number: 3004142400-2020-00005
• Device Sequence Number: 4579374
• 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: 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): 03/01/2024

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 33 YR
• Patient Sex: Male