NobelActive® TiUltra™ 300251Recalls & reported problems
Nobel Biocare AB · NobelActive® TiUltra™ RP 4.3x10mm · Class 2 · Implant
All models of NobelActive TiUltra (28)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This NobelActive TiUltra dental implant appears in 10,244 adverse event reports: 10,122 describe injuries and 122 describe malfunctions, with no deaths. The reports mostly describe implants that fail to bond with the jawbone or later lose that bond, along with fractures, infection, inflammation and abscesses around the implant. 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
- 10,351
- Deaths reported
- 0
- Injuries reported
- 10,229
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10,351 adverse event reports that list this exact device (DI 07332747127423), received between Oct 29, 2021 and Sep 30, 2026 — classified as 10,229 injuries, 122 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (7,054 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate7,054
- Loss of Osseointegration1,644
- Osseointegration Problem869
- Adverse Event Without Identified Device or Use Problem250
- Patient Device Interaction Problem153
- Fracture110
- Migration82
- Insufficient Device Problem Information42
Patient problems
- Failure of Implant6,462
- No Clinical Signs, Symptoms or Conditions2,782
- Unspecified Infection846
- Pain678
- Inflammation184
- Abscess169
- Implant Pain139
- Numbness108
Recent adverse event reports
The 25 most recent of 10,351 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954027 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954024 ↗InjurySep 30, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953313 ↗InjurySep 30, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953312 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953121 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953119 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940775 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940773 ↗InjurySep 29, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940687 ↗InjurySep 29, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940685 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940641 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940639 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50940485 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50940484 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50940395 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50940392 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: Inflammation
MAUDE report 50940314 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: Inflammation
MAUDE report 50940289 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940022 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940021 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50833620 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50833615 ↗InjurySep 19, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833599 ↗InjurySep 19, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833598 ↗InjurySep 19, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833419 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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