EVEREST® Spinal System 2901-08590GRecalls & reported problems
VB Spine LLC · Polyaxial Screw, Closed Size Ø8.5x90 mm · Class 2 · Implant
All models of EVEREST Spinal System (77)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888857037700), received between May 20, 2020 and Feb 12, 2026 — classified as 4 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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
- Device Dislodged or Dislocated4
- Fracture1
- Material Separation1
Patient problems
- Insufficient Information4
- Pain2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryFeb 12, 2026Device Dislodged or Dislocated
THE DEVICES WERE IMPLANTED FOR APPROXIMATELY 9 MONTHS.
Patient problems: Insufficient Information
MAUDE report 24326358 ↗InjuryFeb 12, 2026Device Dislodged or Dislocated
THE DEVICES WERE IMPLANTED FOR APPROXIMATELY 9 MONTHS.
Patient problems: Insufficient Information
MAUDE report 24326347 ↗InjuryOct 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS TWO EVEREST POLYAXIAL SCREW TULIP DISENGAGEMENTS. THIS REPORT CAPTURES THE SECOND OF TWO SCREWS.
Patient problems: Insufficient Information; Pain
MAUDE report 23439760 ↗InjuryOct 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS TWO EVEREST POLYAXIAL SCREW TULIP DISENGAGEMENTS. THIS REPORT CAPTURES THE FIRST OF TWO SCREWS.
Patient problems: Insufficient Information; Pain
MAUDE report 23439759 ↗MalfunctionMay 20, 2020Fracture; Material Separation; Fracture; Material Separation
PHYSICIAN REPORTED THAT TWO EVEREST SPINAL SYSTEM POLYAXIAL SCREWS "BROKE" DURING REVISION SURGERY. SURGERY WAS SUCCESSFULLY COMPLETED WITH A 20 MINUTE DELAY. NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED. THIS REPORT CAPTURES THE SECOND OF TWO SCREWS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10077570 ↗
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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