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

Model Number	151.051
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was a revision surgery to replace a fortify spacer that had collapsed post operatively.
Additional Manufacturer Narrative
The device was returned for evaluation.Initial observation of the micro-ct scanned shows tissue inside of the inserter hole touching the lock.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.

• Brand Name: FORTIFY
• 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: 15844918
• Report Number: 3004142400-2022-00168
• Device Sequence Number: 17637860
• 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): 11/22/2022

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: BAA341SP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2022
• 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: 66 YR
• Patient Sex: Male
• Patient Race: White