MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RESONATE; RESONATE PLATE

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device was not available for evaluation as it remains in the patient.The imaging shows what appears to be a small metal fragment protruding from the plate, possibly a piece of the locking slider.It is unclear if it is a portion of the plate or some other foreign matter.No determinations could be made as to the cause of the reported issue.

Event Description

It was reported that a resonate plate appears to have been bent post operatively.

• Brand Name: RESONATE
• Type of Device: RESONATE PLATE
• 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: 18837600
• MDR Text Key: 337213616
• Report Number: 3004142400-2023-00172
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/27/2023
• Initial Date FDA Received: 03/05/2024
• 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