EVEREST® Spinal System 2901-10001-SGRecalls & reported problems

VB Spine LLC · Set Screw ATR™ · Class 2 · Implant

All models of EVEREST Spinal System (77)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 6
Deaths reported: 0
Injuries reported: 6
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10888857037946), received between Aug 4, 2020 and Apr 10, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Migration” (6 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Migration6

Patient problems

No Clinical Signs, Symptoms or Conditions6
Injury1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

InjuryApr 10, 2024Migration; Migration
IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST-OPERATIVELY A PATIENT WAS REVISED TO ADDRESS THE MIGRATION OF FIVE EVEREST SET SCREWS FROM THE SCREW HEAD AFTER THE FINAL CLOSURE. THIS REPORT CAPTURES THE FIFTH OF FIVE EVEREST SET SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19080349 ↗
InjuryNov 22, 2023Migration; Migration
A PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY TWO MONTHS AFTER IMPLANTATION TO ADDRESS FIVE MIGRATED EVEREST SET SCREWS. THIS REPORT CAPTURES THE THIRD OF FIVE EVEREST SET SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18193872 ↗
InjuryNov 22, 2023Migration; Migration
A PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY TWO MONTHS AFTER IMPLANTATION TO ADDRESS FIVE MIGRATED EVEREST SET SCREWS. THIS REPORT CAPTURES THE FOURTH OF FIVE EVEREST SET SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18193870 ↗
InjuryNov 22, 2023Migration; Migration
A PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY TWO MONTHS AFTER IMPLANTATION TO ADDRESS FIVE MIGRATED EVEREST SET SCREWS. THIS REPORT CAPTURES THE FIRST OF FIVE EVEREST SET SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18193867 ↗
InjuryNov 22, 2023Migration; Migration
A PATIENT UNDERWENT REVISION SURGERY APPROXIMATELY TWO MONTHS AFTER IMPLANTATION TO ADDRESS FIVE MIGRATED EVEREST SET SCREWS. THIS REPORT CAPTURES THE SECOND OF FIVE EVEREST SET SCREWS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18193865 ↗
InjuryAug 4, 2020Migration; Migration
IT WAS DISCOVERED VIA X-RAY, THAT AN EVEREST ATR SET SCREW HAD MIGRATED CAUSING A ROD TO MOVE FROM ITS ORIGINAL POSITION ON THE POSTERIOR SPINE. ADDITIONALLY, A VERTEBRAL BODY REPLACEMENT ON THE ANTERIOR SPINE DISLOCATED. REVISION SURGERY WAS PERFORMED. THIS REPORT REPRESENTS THE EVEREST SET SCREW.
Patient problems: Injury; No Clinical Signs, Symptoms or Conditions
MAUDE report 10364913 ↗

Device details

UDI-DI	`10888857037946`
Brand	EVEREST® Spinal System
Model	2901-10001-SG
Company	VB Spine LLC
Product code	NKB · Orthosis, spinal pedicle fixation, for degenerative disc disease
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Apr 20, 2026

Device type (GMDN): Spinal bone screw, non-bioabsorbable

A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

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All Orthosis, spinal pedicle fixation, for degenerative disc disease devices →

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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