NA 0362Recalls & reported problems

Medtronic Xomed, Inc. · PROSTHESIS 0362 H/A NOTCHED OFFSET PART · Class 2 · Implant

Data updated Oct 13, 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 20681490017880), received between Sep 27, 2019 and Sep 27, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 Separation1

Patient problems

No Consequences Or Impact To Patient1
No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

MalfunctionSep 27, 2019Material Separation; Material Separation
A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE NOTCHED OFFSET PARTIAL EAR FELL APART WHILE THE DOCTOR WAS PLACING IT ON A PATIENT. THE DEVICE DID NOT MAKE IT TO THE PATIENT. THE DEVICE WAS HELD ON AN INSTRUMENT WHEN IT FELL APART. THERE WAS NO KNOWN PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9130257 ↗

Device details

UDI-DI	`20681490017880`
Brand	NA
Model	0362
Company	Medtronic Xomed, Inc.
Product code	ETA · REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
Class	Class 2
FDA submission	K885201
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jul 6, 2018

Device type (GMDN): Ossicular prosthesis, partial

A sterile device intended to be implanted for the functional reconstruction of segments of the ossicular chain (mallues, incus, and/or stapes bones) to facilitate the conduction of sound waves from the tympanic membrane to the inner ear. It is designed to treat conductive hearing loss from traumatic or surgical injury, otosclerosis, congenital fixation of the stapes, or chronic middle ear disease. The device is typically in the form of a tube made of metal [e.g., stainless steel, titanium (Ti)], polymers, or a combination of these materials.

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All REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL 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 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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