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

Model Number 151.051

Device Problem Collapse (1099)

Patient Problem Failure of Implant (1924)

Event Date 10/28/2022

Event Type  malfunction  

Event Description

It was reported there was a revision surgery to replace a fortify spacer that had collapsed post operatively.

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
• Type of Device: 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
• MDR Text Key: 304829729
• Report Number: 3004142400-2022-00168
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 00889095042894
• UDI-Public: 00889095042894
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Race: White