MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. FORTIFY CORPECTOMY SPACER; FORTIFY Ø12MM CORE, HEIGHT 19-25MM

Model Number	151.051
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision surgery was performed to replace a fortify core that collapsed 4 months post operatively.
Additional Manufacturer Narrative
The device was returned for evaluation.Initial observation shows bio-material and other material of an unknown origin visible against the lock inside the inserter hold of the implant.The implant shows wear as a result of the manner in which it was originally inserted into the patient by using a trial holder and a gear driver.It's possible that excessive force or bio-material was permitted to enter the inserter hold prior to attachment to the instrument may have caused the cage to collapse.However, an exact cause of the reported issue could not be determined.

• Brand Name: FORTIFY CORPECTOMY SPACER
• Common Device Name: FORTIFY Ø12MM CORE, HEIGHT 19-25MM
• 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: 15692665
• Report Number: 3004142400-2022-00153
• Device Sequence Number: 12462735
• Product Code: MQP
• UDI-Device Identifier: 00889095042894
• UDI-Public: 00889095042894
• 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
• Report Date (Section B): 10/24/2022

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: 151.051
• Device Lot Number: BAY410SN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2021
• 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 Age: 55 YR
• Patient Sex: Male