NobelActive® TiUltra™ 300245Recalls & reported problems
Nobel Biocare AB · NobelActive® TiUltra™ NP 3.5x10mm · Class 2 · Implant
All models of NobelActive TiUltra (28)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare NobelActive implant is placed in bone. Reports mostly describe the implant failing to bond with the surrounding bone, along with infection, pain, and abscesses. There are 7,404 reports, with no deaths and 7,310 injuries. 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
- 7,505
- Deaths reported
- 0
- Injuries reported
- 7,411
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7,505 adverse event reports that list this exact device (DI 07332747127362), received between Oct 29, 2021 and Sep 30, 2026 — classified as 7,411 injuries, 94 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (5,226 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 Osseointegrate5,226
- Loss of Osseointegration1,167
- Osseointegration Problem503
- Adverse Event Without Identified Device or Use Problem174
- Fracture156
- Patient Device Interaction Problem84
- Migration64
- Difficult to Insert32
Patient problems
- Failure of Implant4,814
- No Clinical Signs, Symptoms or Conditions1,971
- Unspecified Infection612
- Pain510
- Abscess119
- Inflammation109
- Implant Pain103
- Numbness94
Recent adverse event reports
The 25 most recent of 7,505 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954187 ↗InjurySep 30, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954186 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954182 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954178 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953538 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953537 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953116 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953115 ↗InjurySep 30, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953055 ↗InjurySep 30, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953054 ↗InjurySep 29, 2026Osseointegration Problem
Patient problems: Unspecified Infection
MAUDE report 50940624 ↗InjurySep 29, 2026Osseointegration Problem
Patient problems: Unspecified Infection
MAUDE report 50940621 ↗InjurySep 29, 2026Osseointegration Problem
Patient problems: Unspecified Infection
MAUDE report 50940603 ↗InjurySep 29, 2026Osseointegration Problem
Patient problems: Unspecified Infection
MAUDE report 50940600 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50940471 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50940464 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940330 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940327 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50940191 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50940180 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50940140 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50940139 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939846 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939844 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939421 ↗
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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