MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RESONATE; RESONATE ANTERIOR CERVICAL PLATE, 2-LEVEL, 30MM

Model Number	1194.2030
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation as it remains in the patient.It was reported that the screws backed out past the locking mechanisms at the top and bottom levels of a 2 level 30mm resonate plate.The original surgery occurred (b)(6) 2023 and the back-out was discovered on the 4 month post-op images (b)(6) 2024.In the immediate post-op image, 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 and the bottom level.There appears to be some collapse of the anterior portion of the vertebral body at the bottom level.It was mentioned that the surgeon believes its potentially a non-fusion.Due to it being unclear whether some damage occurred to the plate or sliders inter-operatively, no determinations can be made as to 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 ANTERIOR CERVICAL PLATE, 2-LEVEL, 30MM
• 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: 18821881
• Report Number: 3004142400-2024-00040
• Device Sequence Number: 4526300
• Product Code: KWQ
• UDI-Device Identifier: 00193982154813
• UDI-Public: 00193982154813
• 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: 2023
• 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): 02/22/2024

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: 1194.2030
• Device Lot Number: ETB115MB
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2023
• 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: Unknown