DENALI® Spinal System 101-555100Recalls & reported problems

VB Spine LLC · 101-555100 · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10888857006041), received between Oct 15, 2015 and Oct 15, 2015.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).

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 16, 2026.

Most reported problems

Device problems

Migration or Expulsion of Device1

Patient problems

No Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

Oct 15, 2015Migration or Expulsion of Device
IT WAS REPORTED TO K2M, INC. ON (B)(6) 2015 THAT A ROD SLIPPED. THE PATIENT REPORTEDLY HAD A SLIPPED ROD APPROXIMATELY 12 MONTHS POST-OP. NO REVISION HAS TAKEN PLACE.
Patient problems: No Information
MAUDE report 5154302 ↗

Device details

UDI-DI	`10888857006041`
Brand	DENALI® Spinal System
Model	101-555100
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	No
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jun 25, 2026

Device type (GMDN): Bone-screw internal spinal fixation system rod

An implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.

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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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