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

Model Number 1194.3048

Device Problem Migration (4003)

Patient Problem Spinal Cord Injury (2432)

Event Type  malfunction  

Manufacturer Narrative

The device was not available as it remains in the patient.It was reported that the screws backed out past the locking mechanisms at the top level of a 3 level 48mm resonate plate at c4-c7.The original surgery occurred (b)(6) 2024 and the back-out was discovered on the 1 month post-op images (b)(6) 2024.In the immediate post-op image provided by the sales rep, the screws appear to be fully seated.The post-op image provided shows the head of at least one screw being proud of the plate at the top level.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.The issue will be re-evaluated at the 3 month follow up.No determinations can be made for 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: 18935123
• MDR Text Key: 338085586
• Report Number: 3004142400-2024-00058
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00193982155377
• UDI-Public: 00193982155377
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1194.3048
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2024
• 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
• Patient Sex: Male