MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. FORTIFY; FORTIFY 12MM CORE, HEIGHT 25-37MM

Model Number	151.053
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Event or Problem Description
A fortify cage lost height post-operatively.A revision surgery has not been performed.
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.Both operative and post-operative images were received and indicate the fortify cage experienced a loss of height but is still partially expanded.The sales representative noted that during the original surgery, the inserter was attached to the core before graft packing and was initially expanded and then later contracted to its final position.It was also noted that the patient was quite active immediately post-op and was given a neck brace as a result which they would not consistently wear.The implant remains in the patient making a complete evaluation impossible.The exact cause of the reported issue cannot be determined.The following sections have been updated: b4, e1, e3, h2, h6, h10.

• Brand Name: FORTIFY
• Common Device Name: FORTIFY 12MM 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: 18825546
• Report Number: 3004142400-2018-00028
• Device Sequence Number: 12699991
• 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
• 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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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