MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. COALITION AGX; COALITION AGX® RP PLATE, 14MM W, 7MM H

Model Number 1128.2207

Device Problem Material Separation (1562)

Patient Problem Failure of Implant (1924)

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device was not returned for evaluation as it remains in the patient.Post-operative lateral x-ray images were provided which appear to show the allograft spacer is disassociated form the plate.The exact cause of the reported issue cannot be determined.

Event Description

It was reported that the coalition agx cage and bone graft had disassociated post-operatively.The patient is experiencing no adverse effects and there is no revision planned.

• Brand Name: COALITION AGX
• Type of Device: COALITION AGX® RP PLATE, 14MM W, 7MM H
• 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: 18832015
• MDR Text Key: 336826541
• Report Number: 3004142400-2018-00061
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142218
• 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: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1128.2207
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: No
• 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: 60 YR
• Patient Sex: Female
• Patient Race: White