EMERGE Anterior Cervical Plate System 100-4L66Recalls & reported problems
Evolution Spine LLC · 4 LEVEL PLATE 66 mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00195860013137), received between Jul 26, 2023 and Jan 8, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Misassembly by Users1
Patient problems
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 8, 2024Misassembly by Users; Misassembly by Users
THE PRIMARY SURGERY OCCURRED ON (B)(6) 2023. EVOLUTION WAS CONDUCTING A CADAVER LAB WITH THE DOCTOR (ON AN UNRELATED PROJECT) ON (B)(6) 2023 (DATE OF AWARENESS) AND HE MENTIONED THAT HE HAD A COVER COME OFF OF AN EMERGE PLATE. THE DOCTOR DID NOT PROVIDE ANY IMAGES OR ADDITIONAL DETAILS OTHER THAN THAT THE LOWEST PLATE COVER WAS SHOWN AS DISPLACED ON A ROUTINE FOLLOW-UP X-RAY. THE DOCTOR SAID THAT THE PATIENT IS FUSED, AND NO REVISION IS PLANNED.
Patient problems: Failure of Implant
MAUDE report 18470274 ↗MalfunctionJul 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
AN EMERGE COVER DISLODGED FROM THE PLATE AFTER THE SURGEON ATTEMPTED TO TURN THE COVER PAST A SCREW THAT WAS BEYOND THE ACCEPTABLE ANGLE. THE SCREW HEAD WAS TOO PROUD AND LED TO THE COVER DISLODGING. THE SURGEON THEN SIMPLY PLACED THE DISLODGED COVER BACK INTO THE PLATE AND CLOSED THE PATIENT. SINCE THE COVER WAS DISLODGED, THE STRENGTH OF THE COVER HAS BEEN COMPROMISED AND MAY INCREASE THE PROBABILITY OF OCCURRENCE OF SCREW BACKOUT. THE SURGEON SHOULD HAVE REPLACED THE PLATE WITH A NEW PLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17396826 ↗
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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