NobelActive® TiUltra™ 300257Recalls & reported problems
Nobel Biocare AB · NobelActive® TiUltra™ RP 5.0x10mm · Class 2 · Implant
Quick summary
This Nobel Biocare NobelActive implant is placed in the jawbone. The reports mostly describe implants that failed to bond with the bone, with some also mentioning infection or pain. FDA records list 5,358 reports, no deaths, 5,298 injuries and 60 malfunctions. 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
- 5,414
- Deaths reported
- 0
- Injuries reported
- 5,354
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5,414 adverse event reports that list this exact device (DI 07332747127485), received between Oct 29, 2021 and Sep 30, 2026 — classified as 5,354 injuries, 60 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (3,685 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate3,685
- Loss of Osseointegration773
- Osseointegration Problem443
- Adverse Event Without Identified Device or Use Problem158
- Patient Device Interaction Problem148
- Migration58
- Insufficient Device Problem Information34
- Difficult to Insert32
Patient problems
- Failure of Implant3,319
- No Clinical Signs, Symptoms or Conditions1,623
- Unspecified Infection372
- Pain342
- Abscess117
- Inflammation60
- Implant Pain56
- Numbness56
Recent adverse event reports
The 25 most recent of 5,414 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953129 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953128 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924782 ↗InjurySep 28, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924781 ↗InjurySep 20, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834859 ↗InjurySep 20, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834847 ↗InjurySep 19, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833584 ↗InjurySep 19, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833576 ↗InjurySep 19, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832791 ↗InjurySep 19, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832790 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830082 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830080 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50811021 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50811017 ↗InjurySep 16, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796316 ↗InjurySep 16, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796314 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796301 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796299 ↗InjurySep 16, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796108 ↗InjurySep 16, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796107 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50781147 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: Unspecified Infection
MAUDE report 50781146 ↗InjurySep 15, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780833 ↗InjurySep 15, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780831 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764603 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.