EVEREST® Spinal System 2911-085110Recalls & reported problems
VB Spine LLC · Polyaxial Screw Size Ø8.5x110 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857042957), received between Aug 13, 2021 and Aug 13, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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
- Fracture2
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.
InjuryAug 13, 2021Fracture; Fracture
IT WAS REPORTED THAT THREE EVEREST POLYAXIAL SCREWS FRACTURED DURING SURGERY. TWO SCREWS BROKE UPON INSERTION. THE THIRD SCREW FRACTURED WHEN THE SURGEON ATTEMPTED TO REMOVE AND REPOSITION IT AFTER DECIDING IT WAS TOO LONG. THERE WAS A SURGICAL DELAY OF MORE THAN TWO HOURS AND THE PROCEDURE WAS NOT COMPLETED AS PLANNED. THIS REPORT CAPTURES THE SECOND OF THE THREE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12321587 ↗InjuryAug 13, 2021Fracture; Fracture
IT WAS REPORTED THAT THREE EVEREST POLYAXIAL SCREWS FRACTURED DURING SURGERY. TWO SCREWS BROKE UPON INSERTION. THE THIRD SCREW FRACTURED WHEN THE SURGEON ATTEMPTED TO REMOVE AND REPOSITION IT AFTER DECIDING IT WAS TOO LONG. THERE WAS A SURGICAL DELAY OF MORE THAN TWO HOURS AND THE PROCEDURE WAS NOT COMPLETED AS PLANNED. THIS REPORT CAPTURES THE THIRD OF THE THREE SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12321583 ↗
Other Orthosis, spinal pedicle fixation, for degenerative disc disease devices
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- Sequoia® 3301-1Zimmer Spine, Inc. · Orthosis, spinal pedicle fixation, for degenerative disc disease184 reports
- 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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