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

Model Number	1194.3048
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Spinal Cord Injury (2432)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that screws are backing out of a resonate plate post operatively.

• Brand Name: RESONATE
• Common Device Name: 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
• Report Number: 3004142400-2024-00058
• Device Sequence Number: 7027005
• Product Code: KWQ
• UDI-Device Identifier: 00193982155377
• UDI-Public: 00193982155377
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K192314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2024

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
• Operator of Device: Health Professional
• Device Model Number: 1194.3048
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male