MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. COALITION AGX; COALITION AGX® RP PLATE, 16MM W, 8MM H

Model Number 1128.2408

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 01/02/2019

Event Type  malfunction  

Event Description

It was reported that the coalition agx plate has separated from the allograft post-operatively requiring revision surgery.

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device was not returned for evaluation as it was discarded by the hospital.Post-operative lateral x-ray images were provided which appear to show the level did not fuse, the allograft was broken, and the head of the screw was not fully seated in the plate.It is indeterminate whether damage occurred to the allograft plate or spacer during the assembly process, during insertion, or if the spacer became disassociated with the plate sometime thereafter, or to what extent the vertebral endplates were prepared.As the parts were not returned, they cannot be evaluated dimensionally or functionally.The exact cause of the reported issue cannot be determined.

• Brand Name: COALITION AGX
• Type of Device: COALITION AGX® RP PLATE, 16MM W, 8MM 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: 18832675
• MDR Text Key: 336830364
• Report Number: 3004142400-2019-00001
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1128.2408
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/02/2019
• Initial Date FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 47 YR
• Patient Sex: Female
• Patient Race: White