MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RESONATE; RESONATE ANTERIOR CERVICAL PLATE, 3-LEVEL, 51MM

Model Number	1194.3051
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not available for evaluation.It was reported that screws are backing out of the top and bottom levels of a 3 level 51mm resonate plate at c3/c6.The original surgery date was (b)(6) 2024.The back outs were discovered on a post-op image (b)(6) 2024.It was reported that there were no complications during the original surgery.The immediate post-op image provided shows the plate over a fortify corpectomy spacer c3-c5 and a hedron c spacer c5-c6.There are no screws in the plate at the c4 level because of the corpectomy at that level.The other screws appear to be fully seated.In the post op image, taken (b)(6) 2024, two screws at the top and two screws at the bottom of the plate appear to be 1-2mm proud of the plate.It was also reported there was no adverse effects, no pain experienced by the patient and no plans for a revision at the time this was reported.It is unclear whether some damage occurred to the plate or sliders inter-operatively or what the cause of the issue could have been.Updates will be provided if more information becomes available.This evaluation determined that this failure was within expected risk; therefore, no further actions will be taken at this time.No determinations can be made 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, 3-LEVEL, 51MM
• 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: 20610227
• Report Number: 3004142400-2024-00248
• Device Sequence Number: 17994948
• Product Code: KWQ
• UDI-Device Identifier: 00193982155384
• UDI-Public: 00193982155384
• 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): 11/04/2024

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: 1194.3051
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 11/05/2024
• 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 Age: 58 YR
• Patient Sex: Male