Modular Fixation System NC055-040-4Recalls & reported problems

Life Spine, Inc. · Bone Screw, 5.5mm x 40mm, Noncannulated · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00190837076603), received between Nov 19, 2021 and Nov 19, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Material Split, Cut or Torn1

Patient problems

Malunion of Bone1

Recent adverse event reports

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

InjuryNov 19, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE SURGEON WHO INITIALLY IMPLANTED HARDWARE SCHEDULED A REVISION OF CENTERLINE. SURGEON'S COLLEAGUE ASSISTED AND DECIDED THEY WANTED TO REMOVE ALL HARDWARE AND REPLACE WITH A DIFFERENT PRODUCT UPON EXPOSURE AND REMOVING HARDWARE, THEY NOTICED ONE COMPLETE SIDE OF SCREWS (3) HAD BROKEN. OTHER SIDE INTACT. HARDWARE IS BEING WASHED, COLLECTED & RETURNED.
Patient problems: Malunion of Bone
MAUDE report 12846380 ↗

Device details

UDI-DI	`00190837076603`
Brand	Modular Fixation System
Model	NC055-040-4
Company	Life Spine, Inc.
Product code	NKB · Thoracolumbosacral pedicle screw system
Class	Class 2
FDA submission	K183430
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 11, 2024

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.

Other Thoracolumbosacral pedicle screw system devices

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All Thoracolumbosacral pedicle screw system devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.