NobelActive® TiUltra™ 300248Recalls & reported problems
Nobel Biocare AB · NobelActive® TiUltra™ NP 3.5x15mm · 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 has 2,203 reports, with 2,146 listed as injuries and no deaths. Most describe the implant failing to osseointegrate, or losing its bond with the jawbone. Some reports also mention infection, pain and numbness, and some describe fractures. 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
- 2,228
- Deaths reported
- 0
- Injuries reported
- 2,171
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,228 adverse event reports that list this exact device (DI 07332747127393), received between Oct 29, 2021 and Sep 30, 2026 — classified as 2,171 injuries, 57 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,526 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 Osseointegrate1,526
- Osseointegration Problem224
- Loss of Osseointegration223
- Fracture63
- Patient Device Interaction Problem63
- Adverse Event Without Identified Device or Use Problem54
- Migration14
- Difficult to Insert12
Patient problems
- Failure of Implant1,433
- No Clinical Signs, Symptoms or Conditions630
- Unspecified Infection176
- Pain162
- Numbness28
- Abscess23
- Fistula16
- Inflammation14
Recent adverse event reports
The 25 most recent of 2,228 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954110 ↗InjurySep 30, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954107 ↗InjurySep 30, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953069 ↗InjurySep 30, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953065 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811481 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811477 ↗InjurySep 17, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811392 ↗InjurySep 17, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811388 ↗InjurySep 16, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796312 ↗InjurySep 16, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796307 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795948 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795945 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795941 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795940 ↗InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749124 ↗InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749123 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743494 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743492 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743231 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743229 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724048 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724046 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50723804 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50723802 ↗InjurySep 9, 2026Failure to Osseointegrate
Patient problems: Implant Pain
MAUDE report 50700730 ↗
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- 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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