RESONATE 1194.3045Recalls & reported problems
Globus Medical, Inc. · RESONATE Anterior Cervical Plate, 3-Level, 45mm · Class 2 · Implant
All models of RESONATE (24)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00193982155360), received between Apr 30, 2021 and Mar 5, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Device Dislodged or Dislocated1
- Device Slipped1
- Loose or Intermittent Connection1
Patient problems
- Failure of Implant2
- Insufficient Information2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2024Break; Break
IT WAS REPORTED THAT A SCREW IS BACKING OUT OF THE RESONATE PLATE POST-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 18838122 ↗MalfunctionJun 30, 2022Loose or Intermittent Connection
IT WAS REPORTED THAT SCREWS ARE BACKING OUT OF THE RESONATE PLATE POST-OPERATIVELY.
Patient problems: Failure of Implant
MAUDE report 14873581 ↗MalfunctionJul 28, 2021Device Slipped
IT WAS REPORTED THAT A RESONATE SCREW IS BACKING OUT OF A PLATE POST-OPERATIVELY.
Patient problems: Insufficient Information
MAUDE report 12242230 ↗MalfunctionApr 30, 2021Device Dislodged or Dislocated
IT WAS REPORTED THAT A REVISION WAS DONE DUE TO A SCREW WHICH HAD BACKED OUT OF THE RESONATE PLATE POST-OPERATIVELY.
Patient problems: Failure of Implant
MAUDE report 11755632 ↗
Other Appliance, fixation, spinal intervertebral body devices
- CD HORIZON® SOLERA® VOYAGER™ Spinal System 6550017Medtronic Sofamor Danek, Inc. · Appliance, fixation, spinal intervertebral body131 reports
- EVEREST® Spinal System 2901-10001VB Spine LLC · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY119 reports
- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430344Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- ATLANTIS® Anterior Cervical Plate System 876-170Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- XLP 7565060Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430113Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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