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

Device Problem Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The device was not available for evaluation as it remains in the patient.Imaging provided shows the screw backing out.Additional information provided that the slider was intact during the revision but the surgeon decided to remove the plate and replace it with an xtend plate.An exact cause to the reported issue could not be determined.

Event Description

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

• Brand Name: RESONATE
• Type of Device: RESONATE ANTERIOR CERVICAL 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: 14321260
• MDR Text Key: 299836430
• Report Number: 3004142400-2022-00067
• 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: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2022
• 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