EVEREST® Spinal System 2911-06540Recalls & reported problems
VB Spine LLC · 2911-06540 · 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
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10888857042315), received between Oct 11, 2019 and Dec 3, 2019 — classified as 5 injuries.
The most frequently reported specific device problem is “Fracture” (3 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
- Fracture3
- Migration2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Injury5
- Pain5
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryDec 3, 2019Migration; Migration
A PHYSICIAN REPORTED THAT TWO EVEREST POLYAXIAL SCREWS MIGRATED POST-OPERATIVELY. REVISION SURGERY IS NOT SCHEDULED. THIS RECORD CAPTURES THE SECOND OF THE TWO POLYAXIAL SCREWS.
Patient problems: Injury; No Known Impact Or Consequence To Patient; Pain
MAUDE report 9403458 ↗InjuryDec 3, 2019Migration; Migration
A PHYSICIAN REPORTED THAT TWO EVEREST POLYAXIAL SCREWS MIGRATED POST-OPERATIVELY. REVISION SURGERY IS NOT SCHEDULED. THIS RECORD CAPTURES THE FIRST OF THE TWO POLYAXIAL SCREWS.
Patient problems: Injury; No Known Impact Or Consequence To Patient; Pain
MAUDE report 9403432 ↗InjuryNov 22, 2019Fracture; Fracture
A PHYSICIAN REPORTED THAT A PATIENT WAS EXPERIENCING PAIN TEN WEEKS POST-OPERATIVELY. FOLLOW-UP REVEALED A BROKEN EVEREST POLYAXIAL SCREW. REVISION SURGERY IS PLANNED BUT HAS NOT BEEN SCHEDULED.
Patient problems: Injury; Pain
MAUDE report 9362712 ↗InjuryOct 11, 2019Fracture
A PHYSICIAN REPORTED THAT TWO EVEREST POLYAXIAL SCREWS IMPLANTED AS S1 HAVE FRACTURED SHAFTS. THE DEVICES REMAIN IMPLANTED IN THE PATIENT AND REVISION SURGERY IS NOT CURRENTLY SCHEDULED. THE PATIENT HAS REPORTED EXPERIENCING PAIN. THIS REPORT CAPTURES THE FIRST OF TWO SCREWS.
Patient problems: Injury; Pain
MAUDE report 9180971 ↗InjuryOct 11, 2019Fracture; Appropriate Device Problem Term/Code Not Available
A PHYSICIAN REPORTED THAT TWO EVEREST POLYAXIAL SCREWS IMPLANTED AS S1 HAVE FRACTURED SHAFTS. THE DEVICES REMAIN IMPLANTED IN THE PATIENT AND REVISION SURGERY IS NOT CURRENTLY SCHEDULED. THE PATIENT HAS REPORTED EXPERIENCING PAIN. THIS REPORT CAPTURES THE SECOND OF TWO SCREWS.
Patient problems: Injury; Pain
MAUDE report 9180717 ↗
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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