EVEREST® Spinal System 2911-35540Recalls & reported problems
VB Spine LLC · 2911-35540 · Class 2 · Implant
All models of EVEREST Spinal System (77)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888857044012), received between Mar 31, 2022 and Oct 24, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Migration” (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
- Migration2
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2025Fracture; Fracture
InjuryMar 31, 2022Migration; Migration
THROUGH CLINICAL SURVEY, A PHYSICIAN REPORTED THAT A PATIENT WAS REVISED TO REMOVE LOOSE HARDWARE. THE PATIENT UNDERWENT A CT SCAN APPROXIMATELY 12-MONTHS POSTOPERATIVELY AND TWO EVEREST UNIPLANAR SCREWS ON THE LEFT SIDE AT L1 AND L2 WERE SEEN TO HAVE MIGRATED. DURING EXPLANT SURGERY, THE PHYSICIAN NOTED THAT THE PATIENT'S FUSION WAS "ROCK SOLID" AND THERE WAS NO NEED TO REPLACE THE INSTRUMENTATION. THIS REPORT CAPTURES THE FIRST OF TWO MIGRATED EVEREST UNIPLANAR SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13971942 ↗InjuryMar 31, 2022Migration; Migration
THROUGH CLINICAL SURVEY, A PHYSICIAN REPORTED THAT A PATIENT WAS REVISED TO REMOVE LOOSE HARDWARE. THE PATIENT UNDERWENT A CT SCAN APPROXIMATELY 12-MONTHS POSTOPERATIVELY AND TWO EVEREST UNIPLANAR SCREWS ON THE LEFT SIDE AT L1 AND L2 WERE SEEN TO HAVE MIGRATED. DURING EXPLANT SURGERY, THE PHYSICIAN NOTED THAT THE PATIENT'S FUSION WAS "ROCK SOLID" AND THERE WAS NO NEED TO REPLACE THE INSTRUMENTATION. THIS REPORT CAPTURES THE SECOND OF TWO MIGRATED EVEREST UNIPLANAR SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13971649 ↗
Other ORTHOSIS, SPINAL PEDICLE FIXATION devices
- NA 04.614.508Synthes GmbH · ORTHOSIS, SPINAL PEDICLE FIXATION277 reports
- CREO 1134.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION112 reports
- CREO 1119.0010Globus Medical, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION80 reports
- VIPER 186731745Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION43 reports
- CD HORIZON® Spinal System 1553201090Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION38 reports
- EXPEDIUM 179902000Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION37 reports
- CD HORIZON® Spinal System 7540220Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION36 reports
- EXPEDIUM VERSE 199721640Medos International Sàrl · ORTHOSIS, SPINAL PEDICLE FIXATION35 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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