MIS UNO MO1-10350Recalls & reported problems

MIS Implants Technologies Ltd. · Uno one piece implant dia. 3.50 L 10mm · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Quick summary

This MIS Uno implant is a narrow, one-piece dental implant used as a tooth root replacement. The 57 reports describe the implant failing to fuse with the jawbone and being lost, sometimes within weeks of surgery and sometimes more than four months later. All 57 reports are injuries, with no deaths. There are no recalls for this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 57
Deaths reported: 0
Injuries reported: 57
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 07290108995992), received between Aug 12, 2024 and Jan 26, 2025 — classified as 57 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (56 reports).

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

Osseointegration Problem56
Failure to Osseointegrate1

Patient problems

Failure of Implant57

Recent adverse event reports

The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

InjuryJan 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 21236896 ↗
InjuryNov 14, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS, MORE THAN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20682098 ↗
InjuryNov 9, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. MORE THAN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20648418 ↗
InjurySep 20, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. MORE THEN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20264594 ↗
InjurySep 19, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. LESS THAN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20256637 ↗
InjurySep 19, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. DAY OF SURGERY/0-4 WEEKS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20253300 ↗
InjurySep 18, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. MORE THEN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20243705 ↗
InjurySep 18, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. DAY OF SURGERY/0-4 WEEKS FROM SURGERY
Patient problems: Failure of Implant
MAUDE report 20243577 ↗
InjurySep 16, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. MORE THAN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20222313 ↗
InjurySep 11, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED, THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. MORE THEN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20191366 ↗
InjurySep 11, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. MORE THEN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20191288 ↗
InjurySep 11, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. DAY OF SURGERY/0-4 WEEKS FROM SURGERY
Patient problems: Failure of Implant
MAUDE report 20187413 ↗
InjurySep 10, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. DAY OF SURGERY/0-4 WEEKS FROM SURGERY
Patient problems: Failure of Implant
MAUDE report 20178111 ↗
InjurySep 5, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. MORE THEN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20142919 ↗
InjurySep 3, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. MORE THEN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20123768 ↗
InjurySep 3, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. MORE THEN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20122930 ↗
InjurySep 3, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. MORE THEN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20122921 ↗
InjurySep 3, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. DAY OF SURGERY/0-4 WEEKS FROM SURGERY
Patient problems: Failure of Implant
MAUDE report 20122747 ↗
InjurySep 2, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. LESS THAN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20117050 ↗
InjurySep 2, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. LESS THEN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20116195 ↗
InjurySep 2, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. LESS THEN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20116187 ↗
InjurySep 2, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. MORE THEN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20116156 ↗
InjurySep 2, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. MORE THEN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20116109 ↗
InjuryAug 27, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. MORE THEN 4 MONTHS FROM SURGERY.
Patient problems: Failure of Implant
MAUDE report 20073921 ↗
InjuryAug 27, 2024Osseointegration Problem; Osseointegration Problem
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS. LESS THEN 4 MONTHS FROM SURGERY
Patient problems: Failure of Implant
MAUDE report 20073802 ↗

Device details

UDI-DI	`07290108995992`
Brand	MIS UNO
Model	MO1-10350
Company	MIS Implants Technologies Ltd.
Product code	DZE · Implant, Endosseous, Root-Form
Class	Class 2
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 17, 2022

Device type (GMDN): Basket endosteal dental implant, two-piece

A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a single, double, and/or triple contiguous cylinder(s) that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

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All Implant, Endosseous, Root-Form 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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