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

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 02/20/2024

Event Type  malfunction  

Event Description

It was reported that screws are backing out of a resonate plate post operatively.

Manufacturer Narrative

The device was not available for evaluation as it remains in the patient.It was reported that the a screw or screws backed out past the locking mechanisms at the inferior level of a 2 level resonate plate.The original surgery date is not known at this time.It was reported that the back-out was discovered on the 6 month post-op follow up.It was described as the head of the screw slightly protruding from the plate, being barely visible, but appeared to be slightly backed out.The screws were 18mm.According to the surgeon the patient was non-symptomatic and fused.It is unclear whether some damage occurred to the plate or sliders inter-operatively or what the cause of the issue could have been.No pain or adverse effect to the patient was reported.There were no plans for a revision at the time the issue was reported.No determinations can be made for the cause of the reported issue.

• 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: 18924827
• MDR Text Key: 337916142
• Report Number: 3004142400-2024-00054
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2024
• 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