EVEREST® Spinal System 2911-095100Recalls & reported problems
VB Spine LLC · 2911-095100 · Class 2 · Implant
All models of EVEREST Spinal System (77)
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 10888857043275), received between Aug 19, 2022 and Aug 19, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Mechanical Problem2
- Migration2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2022Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Migration; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Migration
IT WAS REPORTED VIA X-RAY THAT TWO (2) EVEREST SACROILIAC SCREWS SHOWED APPARENT BACK OUT AND DISENGAGEMENT POST-OPERATIVELY. THE X-RAY PROVIDED ALSO SHOWS MIGRATION OF TWO (2) ASSOCIATED EVEREST SET SCREWS. REVISION SURGERY HAS NOT BEEN PERFORMED OR SCHEDULED AT THIS TIME. THIS REPORT CAPTURES THE SECOND OF THE TWO EVEREST SACROILIAC SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15258525 ↗MalfunctionAug 19, 2022Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Migration; Mechanical Problem; Adverse Event Without Identified Device or Use Problem; Migration
IT WAS REPORTED VIA X-RAY THAT TWO (2) EVEREST SACROILIAC SCREWS SHOWED APPARENT BACK OUT AND DISENGAGEMENT POST-OPERATIVELY. THE X-RAY PROVIDED ALSO SHOWS MIGRATION OF TWO (2) ASSOCIATED EVEREST SET SCREWS. REVISION SURGERY HAS NOT BEEN PERFORMED OR SCHEDULED AT THIS TIME. THIS REPORT CAPTURES THE FIRST OF THE TWO EVEREST SACROILIAC SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15258522 ↗
Other Orthosis, spinal pedicle fixation, for degenerative disc disease devices
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- CD HORIZON® Spinal System 8590855Medtronic Sofamor Danek, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease179 reports
- Vitality® 07.02011.001Biomet Spine LLC · Orthosis, spinal pedicle fixation, for degenerative disc disease3 recalls0 reports
- EXPEDIUM VERSE 199721001SMedos International Sàrl · Thoracolumbosacral pedicle screw system124 reports
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- EXPEDIUM VERSE 199721000SMedos International Sàrl · Thoracolumbosacral pedicle screw system97 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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