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

Device Problem Fracture (1260)

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 unavailable for evaluation as it remains in the patient.It was reported that a screw is backing out of a 3 level resonate plate at c4-c7 post-operatively.The date of original surgery was (b)(6) 2023.The issue was discovered (b)(6) 2023 during a patient follow-up clinic appointment which revealed a screw backing out of the plate.The screw was reported to be a ø4.2 x13mm variable angle, self-tapping screw.No determinations can be made as to the cause of the reported issue.

Event Description

It was reported that screws are backing out of a resonate plate 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: 18827044
• MDR Text Key: 336815618
• Report Number: 3004142400-2024-00002
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/02/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• 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