EMERGE Anterior Cervical Plate System 100-4L70Recalls & reported problems
Evolution Spine LLC · 4 LEVEL PLATE 70 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 00195860013144), received between Mar 22, 2024 and Mar 22, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Misassembly by Users” (2 reports).
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
- Misassembly by Users2
Patient problems
- Failure of Implant2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 22, 2024Misassembly by Users; Misassembly by Users
THE PRIMARY SURGERY OCCURRED ON (B)(6) 2022. DR HAD A PATIENT RECEIVE NORMAL POST-OP X-RAYS DURING ROUTINE FOLLOW-UP (THE FOLLOW-UP OCCURRED 15 MONTHS AFTER PRIMARY SURGERY). AFTER REVIEWING THE X-RAY DR NOTED THAT THE TOP LOCKING CAP HAD DISLODGED.
Patient problems: Failure of Implant
MAUDE report 18959686 ↗MalfunctionMar 22, 2024Misassembly by Users; Misassembly by Users
THE PRIMARY SURGERY OCCURRED ON (B)(6) 2023. DR HAD A PATIENT RECEIVE NORMAL 3-MONTH POST-OP X-RAYS DURING ROUTINE FOLLOW-UP. AFTER REVIEWING THE X-RAY DR NOTED THAT THE BOTTOM LOCKING CAP HAD DISLODGED. DR IS CURRENTLY OBSERVING THE PATIENT AND HAS NO PLANS TO REVISE. IT WAS NOTED THAT THE PLATE WAS BENT NEAR OR AROUND THE LOCKING MECHANISM.
Patient problems: Failure of Implant
MAUDE report 18959652 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page