Axium™ MN12150Recalls & reported problems

Spinal Modulation, Inc. · 22cm Small Curve Delivery Sheath Kit · Class 3

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

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 05415067025609), received between Oct 1, 2023 and Oct 1, 2023 — classified as 1 injury.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

InjuryOct 1, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT OF THE PATIENT'S ANCHORS (INCLUDED IN THE SMALL CURVE DELIVERY SHEATH KIT) MIGRATED DURING THE IMPLANT PROCEDURE ON (B)(6) 2023. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE ANCHOR ATTRIBUTED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17849605 ↗

Device details

UDI-DI	`05415067025609`
Brand	Axium™
Model	MN12150
Company	Spinal Modulation, Inc.
Product code	PMP · Dorsal root ganglion stimulator for pain relief
Class	Class 3
FDA submission	P150004
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Jul 6, 2018

Device type (GMDN): Neurosurgical procedure kit, non-medicated, single-use

A collection of various sterile neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a single-use device.

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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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