NobelActive® S TiUltra™ 302275Recalls & reported problems
Nobel Biocare AB · NobelActive® S TiUltra™ NP 3.5x11.5mm · Class 2 · Implant
All models of NobelActive S TiUltra (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07332747221961), received between Jul 1, 2026 and Sep 17, 2026 — classified as 12 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (8 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 Osseointegrate8
- Osseointegration Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- Aspiration/Inhalation2
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Aspiration/Inhalation
MAUDE report 50811088 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Aspiration/Inhalation
MAUDE report 50811083 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796070 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796069 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796068 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796065 ↗InjuryAug 21, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50382119 ↗InjuryAug 21, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50382093 ↗InjuryJul 27, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50026976 ↗InjuryJul 27, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50026937 ↗InjuryJul 1, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25683473 ↗InjuryJul 1, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25683471 ↗
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