MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RESONATE EXTREME ANGLE ANTERIOR CERVICAL PLATE SYSTEM; RESONATE ANTERIOR CERVICAL PLATE, EXTRA LORDOTIC, 2-LEVEL, 26MM

Model Number 1194.2126

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that a screw is backing out of a resonate plate post operatively.

Manufacturer Narrative

This report is being resubmitted for an incident that occurred earlier.The device was not available for evaluation.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.

• Brand Name: RESONATE EXTREME ANGLE ANTERIOR CERVICAL PLATE SYSTEM
• Type of Device: RESONATE ANTERIOR CERVICAL PLATE, EXTRA LORDOTIC, 2-LEVEL, 26MM
• 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: 18822146
• MDR Text Key: 336746529
• Report Number: 3004142400-2023-00049
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192314
• 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: 03/01/2024

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
• Device Model Number: 1194.2126
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 03/01/2024
• 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