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

Model Number 151.051

Device Problem Collapse (1099)

Patient Problem Failure of Implant (1924)

Event Date 09/30/2022

Event Type  malfunction  

Event Description

It was reported that a revision surgery was performed to replace a fortify core that collapsed 4 months post operatively.

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
• 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: 15692665
• MDR Text Key: 303424989
• Report Number: 3004142400-2022-00153
• 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: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• 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: BAY410SN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Date Manufacturer Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2021
• 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: 55 YR
• Patient Sex: Male