NobelActive® TiUltra™ 300266Recalls & reported problems
Nobel Biocare AB · NobelActive® TiUltra™ WP 5.5x13mm · Class 2 · Implant
All models of NobelActive TiUltra (28)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a Nobel Biocare NobelActive dental implant. The 612 reports mostly describe the implant failing to bond with the bone, with some noting implant loss and infection. There are 606 injuries and no deaths. 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
- 626
- Deaths reported
- 0
- Injuries reported
- 620
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 626 adverse event reports that list this exact device (DI 07332747127577), received between Oct 29, 2021 and Sep 30, 2026 — classified as 620 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (410 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 Osseointegrate410
- Osseointegration Problem84
- Loss of Osseointegration64
- Patient Device Interaction Problem22
- Difficult to Insert12
- Migration12
- Adverse Event Without Identified Device or Use Problem8
- Activation, Positioning or Separation Problem4
Patient problems
- Failure of Implant370
- No Clinical Signs, Symptoms or Conditions209
- Unspecified Infection38
- Pain26
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
- Foreign Body In Patient6
- Abscess4
- Bone Fracture(s)4
Recent adverse event reports
The 25 most recent of 626 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 50953068 ↗InjurySep 30, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953064 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940261 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940260 ↗InjurySep 29, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940255 ↗InjurySep 29, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940253 ↗InjurySep 16, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796310 ↗InjurySep 16, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796309 ↗InjurySep 16, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795895 ↗InjurySep 16, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795893 ↗InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748952 ↗InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748950 ↗InjuryAug 26, 2026Failure to Osseointegrate
Failure to osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50462196 ↗InjuryAug 26, 2026Failure to Osseointegrate
Failure to Osseo integrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50462195 ↗InjuryAug 25, 2026Loss of Osseointegration
Patient problems: Unspecified Infection
MAUDE report 50441481 ↗InjuryAug 25, 2026Loss of Osseointegration
InjuryAug 21, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50382508 ↗InjuryAug 21, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50382270 ↗InjuryAug 21, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50382240 ↗InjuryAug 21, 2026Failure to Osseointegrate
InjuryAug 13, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50243071 ↗InjuryAug 13, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50243069 ↗InjuryAug 5, 2026Failure to Osseointegrate
Failure to osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50149213 ↗InjuryAug 5, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50149212 ↗InjuryJul 27, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50027578 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
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- 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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