Tx™ LS-397-0705Recalls & reported problems

INNO Holdings, Inc. · Ti 6Al 4V (ELI) · Class 2

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 M711LS39707050), received between Aug 15, 2024 and Aug 15, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.

Reports received per month

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

Most reported problems

Device problems

Improper or Incorrect Procedure or Method1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionAug 15, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
DURING SURGERY, A TX TRIAL LS-397 BROKE OFF OF THE INSERTER LS-395. THE TRIAL WAS LEFT IMPLANTED IN THE PATIENT INSTEAD OF BEING REPLACED WITH THE INTENDED CAGE, AND GRAFT WAS PACKED AROUND IT. THE SURGEON DID NOT WANT TO TRY AND REMOVE THE STUCK TRIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19996683 ↗

Device details

UDI-DI	`M711LS39707050`
Brand	Tx™
Model	LS-397-0705
Company	INNO Holdings, Inc.
Product code	MAX · Intervertebral Fusion Device With Bone Graft, Lumbar
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jan 15, 2026

Device type (GMDN): Spinal implant trial

A copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

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