NobelActive® TiUltra™ 300260Recalls & reported problems
Nobel Biocare AB · NobelActive® TiUltra™ RP 5.0x15mm · 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 dental implant is a root-form implant set into the jawbone. Most of its 452 reports describe implants that failed to bond with the jawbone or lost their bond later, and some mention infection, abscess or pain. The reports list 445 injuries, no deaths and 7 malfunctions, and no recalls name this device. Reports rose to 112 in the most recent year from 66 in the year before.
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
- 458
- Deaths reported
- 0
- Injuries reported
- 451
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 458 adverse event reports that list this exact device (DI 07332747127515), received between Nov 1, 2021 and Sep 19, 2026 — classified as 451 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (279 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 Osseointegrate279
- Osseointegration Problem68
- Loss of Osseointegration46
- Patient Device Interaction Problem26
- Adverse Event Without Identified Device or Use Problem14
- Migration9
- Activation, Positioning or Separation Problem4
- Difficult to Insert4
Patient problems
- Failure of Implant274
- No Clinical Signs, Symptoms or Conditions134
- Pain30
- Unspecified Infection28
- Abscess12
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available10
- Implant Pain6
- Numbness6
Recent adverse event reports
The 25 most recent of 458 reports, in the reporter's own words as published by the FDA.
InjurySep 19, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833581 ↗InjurySep 19, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833580 ↗InjurySep 16, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796308 ↗InjurySep 16, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796300 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796264 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796262 ↗InjuryAug 8, 2026Failure to Osseointegrate
InjuryAug 8, 2026Failure to Osseointegrate
InjuryAug 8, 2026Failure to Osseointegrate
InjuryAug 8, 2026Failure to Osseointegrate
InjuryAug 7, 2026Failure to Osseointegrate
InjuryAug 7, 2026Failure to Osseointegrate
InjuryJul 16, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25848985 ↗InjuryJul 16, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25848982 ↗InjuryJul 15, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25832638 ↗InjuryJul 15, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25832572 ↗InjuryJul 7, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25740860 ↗InjuryJul 7, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25740785 ↗InjuryJul 1, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25683903 ↗InjuryJul 1, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25683898 ↗InjuryJun 18, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25553998 ↗InjuryJun 18, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25553996 ↗InjuryJun 5, 2026Failure to Osseointegrate
InjuryJun 5, 2026Failure to Osseointegrate
InjuryJun 4, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25402023 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page