MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RESONATE; RESONATE ANTERIOR CERVICAL PLATE, 2-LEVEL, 32MM

Model Number	1194.2030
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation.It was reported that a screw backed out past the locking mechanism at the bottom level of a 2 level, 30mm resonate plate at c5-c7.The original surgery date was (b)(6) 2024.The back-out was discovered 8/13/2024.In the images provided, the screws appear to be fully seated in the intra-op image.The image from 8/13/2024 shows 2 - 3 millimeters of a screw head being proud of the plate at the bottom 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.There was no adverse effect to the patient.This evaluation determined that this failure was within expected risk; therefore, no further actions are required.No determinations can be made as for the cause of the reported issue.
Event or Problem Description
It was reported that resonate screws are backing out of the plate post-operatively.

• Brand Name: RESONATE
• Common Device Name: RESONATE ANTERIOR CERVICAL PLATE, 2-LEVEL, 32MM
• 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: 20192630
• Report Number: 3004142400-2024-00198
• Device Sequence Number: 7535448
• Product Code: KWQ
• UDI-Device Identifier: 00193982154837
• UDI-Public: 00193982154837
• 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
• 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): 09/11/2024

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 09/11/2024
• 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
• Patient Weight: 29 KG