MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. RESONATE; SPINAL FIXATION PLATE, NON-BIOABSORBABLE

Model Number	1194.3048
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	10/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was unavailable for evaluation.No determinations could be made as to the cause of the reported issue.
Event or Problem Description
It was reported that a 3 level resonate plate had a screw back out to the point the screw was sitting 9.1mm proud.The pt came into er complaining of severe pain when swallowing and discomfort.The screw blocking mechanism seems to be broken/damaged in 4 screw holes.
Additional Manufacturer Narrative
The purpose of this rationale is to evaluate the risk associated with the identified failure mode of screw pushes out the top of the plate post-op for the resonate anterior cervical plate system.The overall observed risk level would equate to which falls in the high-risk level.This evaluation determined that this failure was within expected risk; therefore, no further actions will be taken at this time, and the hazard will continue to be monitored.The following sections were updated for this supplemental report.
Event or Problem Description
It was reported that a 3 level resonate plate had a screw back out to the point the screw was sitting 9.1mm proud.The pt came into er complaining of severe pain when swallowing and discomfort.The screw blocking mechanism seems to be broken/damaged in 4 screw holes.

• Brand Name: RESONATE
• Common Device Name: SPINAL FIXATION PLATE, NON-BIOABSORBABLE
• 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: 23526038
• Report Number: 3004142400-2025-00269
• Device Sequence Number: 13303935
• Product Code: KWQ
• UDI-Device Identifier: 00193982155377
• UDI-Public: 00193982155377
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K192314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1194.3048
• Device Lot Number: ETX011AA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2020
• 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