MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RESONATE; RESONATE ANTERIOR CERVICAL PLATE, 2-LEVEL, 20MM

Model Number	1194.2020
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a revision was needed to replace resonate screws backing out of the plate post-operatively.
Additional Manufacturer Narrative
Neither the device nor any imaging was available for evaluation.It was reported that there was revision surgery to remove a screw that backed out of the c7 level of a 2 level, 20mm resonate plate at c6/7.The original surgery date was (b)(6) 2024.The revision date was (b)(6) 2024.It was reported that the patient had been fused at c3-c5 prior to this c6/7 surgery.The technique used was to drill with a drill guide and use self-drilling screws.It is unclear whether some damage occurred to the plate or sliders inter-operatively or what the cause of the issue could have been.It was also stated that there was a pcf after the screw back out.This evaluation determined that this failure was within expected risk; therefore, no further actions will be taken at this time.No determinations could be made as to the cause of the reported issue.

• Brand Name: RESONATE
• Common Device Name: RESONATE ANTERIOR CERVICAL PLATE, 2-LEVEL, 20MM
• 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: 20538314
• Report Number: 3004142400-2024-00238
• Device Sequence Number: 12422483
• Product Code: KWQ
• UDI-Device Identifier: 00193982154714
• UDI-Public: 00193982154714
• 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
• Device Explanted 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): 10/25/2024

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: 1194.2020
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 10/25/2024
• 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: 77 YR
• Patient Sex: Male