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

Model Number	1194.7216
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw backed out of resonate plate.
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.There was a revision surgery on (b)(6) 2025 to remove the screw and add posterior fixation to the affected levels.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.

• Brand Name: RESONATE
• Common Device Name: SPINAL BONE SCREW, 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: 24735047
• Report Number: 3004142400-2026-00055
• Device Sequence Number: 21438005
• Product Code: KWQ
• UDI-Device Identifier: 00193982152765
• UDI-Public: 00193982152765
• 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: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

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: 1194.7216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/30/2026
• 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 Race: White