N/A 1528120Recalls & reported problems

Medtronic Xomed, Inc. · SPLINT 1528120 25PK EXTERNAL NASAL MED · Class 1

Data updated Oct 13, 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 20681490042196), received between Dec 27, 2018 and Dec 27, 2018 — classified as 1 injury.

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

Adverse Event Without Identified Device or Use Problem1

Patient problems

Injury1

Recent adverse event reports

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

InjuryDec 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON FOLLOW-UP, IT WAS CONFIRMED THAT THE INJURY DURING THE RHINOPLASTY PROCEDURE DID NOT COME FROM THE EXTERNAL NASAL SPLINT; THERE WAS NO DEVICE FAILURE OR MALFUNCTION. A NON MEDTRONIC ABRASION DEVICE WAS USED WHICH CAUSED THE INJURY AND NO OTHER PRODUCT INFORMATION PROVIDED. THERE WAS NO EXPLANATION ON HOW THE INJURY WAS RESOLVED AND NO ADDITIONAL INTERVENTION OR ACTIONS DONE TO THE PATIENT. THERE WAS NO BACK UP DEVICE USED.
Patient problems: Injury
MAUDE report 8200619 ↗

Device details

UDI-DI	`20681490042196`
Brand	N/A
Model	1528120
Company	Medtronic Xomed, Inc.
Product code	EPP · SPLINT, NASAL
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Mar 11, 2021

Device type (GMDN): External nasal splint

A rigid or semi-rigid device intended to be applied externally to the nose for the immobilization of nasal bones and cartilage, typically after a fracture or surgery. It functions as a truss-like support on the outside of the nose. This is a single-use device.

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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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