MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. PATRIOT SPACER SYSTEM; SIGNATURE TLIF SPACER, TI LARGE, 8MM

Model Number 168.348/168.349

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 12/16/2022

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The articulating sphere subcomponents were returned disassembled from the implants.Initial observation showed one of the spheres measuring undersized on both the implant width between the sphere flats and sphere nubs, but this is likely due to noted wear on the part from disassembly.A large amount of damage is visible on the other sphere.The imaging provided show the implant placed at l4/l5 appearing to be off center laterally and the implant endplates do not appear parallel to the shot.Additional information provided that this could be due to the angle of the c-arm when the shot was taken, and may not indicate that the implant doesn't have proper endplate contact with the l4/l5 vertebral bodies.The l3/l4 implant appears to be slightly over-medialized, but it is not possible to definitively tell with the provided image.No determinations could be made as to the cause of the reported issue.The following sections have been updated for this supplemental report: b4, e1, h2, h6, h10.

Event Description

It was reported that during a case a signature tlif spacer broke during insertion, causing a dural tear while moving implant.

• Brand Name: PATRIOT SPACER SYSTEM
• Type of Device: SIGNATURE TLIF SPACER, TI LARGE, 8MM
• 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: 18818562
• MDR Text Key: 336991834
• Report Number: 3004142400-2023-00016
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122097
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 168.348/168.349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2023
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 Sex: Male