NobelActive® TiUltra™ 300263Recalls & reported problems

Nobel Biocare AB · NobelActive® TiUltra™ WP 5.5x8.5mm · Class 2 · Implant

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

Quick summary

This is the Nobel Biocare NobelActive TiUltra implant, a dental implant placed in the jawbone. The 1,629 reports mostly describe the implant failing to bond with the surrounding bone, and some mention pain, infection, and punctures of the sinus. The records include no deaths, 1,609 injuries and 20 malfunctions, and no recalls name 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: 1,656
Deaths reported: 0
Injuries reported: 1,636
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1,656 adverse event reports that list this exact device (DI 07332747127539), received between Nov 1, 2021 and Sep 30, 2026 — classified as 1,636 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (1,122 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. 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

Failure to Osseointegrate1,122
Loss of Osseointegration272
Osseointegration Problem132
Adverse Event Without Identified Device or Use Problem38
Patient Device Interaction Problem32
Malposition of Device14
Migration14
Activation, Positioning or Separation Problem8

Patient problems

Failure of Implant1,024
No Clinical Signs, Symptoms or Conditions526
Unspecified Infection74
Pain72
Sinus Perforation36
Inflammation28
Abscess12
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available10

Recent adverse event reports

The 25 most recent of 1,656 reports, in the reporter's own words as published by the FDA.

InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954155 ↗
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954154 ↗
InjurySep 19, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50833604 ↗
InjurySep 19, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50833603 ↗
InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830372 ↗
InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830371 ↗
InjurySep 16, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796097 ↗
InjurySep 16, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796092 ↗
InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749141 ↗
InjurySep 14, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749140 ↗
InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749088 ↗
InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749087 ↗
InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743279 ↗
InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743278 ↗
InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743275 ↗
InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743274 ↗
InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724054 ↗
InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724051 ↗
InjurySep 10, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50723862 ↗
InjurySep 10, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50723861 ↗
InjurySep 9, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50701144 ↗
InjurySep 9, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50701137 ↗
InjurySep 9, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50700879 ↗
InjurySep 9, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50700878 ↗
InjurySep 8, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678781 ↗

Device details

UDI-DI	`07332747127539`
Brand	NobelActive® TiUltra™
Model	300263
Company	Nobel Biocare AB
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	MR Conditional
Status	In Commercial Distribution
Record updated	Jul 7, 2025

Device type (GMDN): Screw 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 threaded screw 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 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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