NobelActive® TiUltra™ 300241Recalls & reported problems
Nobel Biocare AB · NobelActive® TiUltra™ 3.0 3.0x11.5mm · 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 placed into bone to support a replacement tooth. The 939 reports mostly describe implants failing to bond with the bone or losing that bond, and mention infections, pain and abscesses. The reports include no deaths and 926 injuries, and 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
- 946
- Deaths reported
- 0
- Injuries reported
- 933
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 946 adverse event reports that list this exact device (DI 07332747127324), received between Nov 2, 2021 and Sep 30, 2026 — classified as 933 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (725 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 Osseointegrate725
- Osseointegration Problem73
- Loss of Osseointegration70
- Adverse Event Without Identified Device or Use Problem26
- Patient Device Interaction Problem22
- Device Markings/Labelling Problem6
- Fracture6
- Insufficient Device Problem Information4
Patient problems
- Failure of Implant624
- No Clinical Signs, Symptoms or Conditions242
- Unspecified Infection82
- Pain60
- Abscess16
- Inflammation12
- Numbness10
- Fistula8
Recent adverse event reports
The 25 most recent of 946 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 50953801 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953798 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830143 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830136 ↗InjurySep 11, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743820 ↗InjurySep 11, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743815 ↗InjurySep 11, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743020 ↗InjurySep 11, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743016 ↗InjurySep 9, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50701124 ↗InjurySep 9, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50701123 ↗InjuryAug 21, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50381937 ↗InjuryAug 18, 2026Loss of Osseointegration
InjuryAug 18, 2026Loss of Osseointegration
InjuryAug 3, 2026Failure to Osseointegrate
InjuryAug 3, 2026Failure to Osseointegrate
InjuryAug 3, 2026Failure to Osseointegrate
InjuryAug 3, 2026Failure to Osseointegrate
InjuryJul 27, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50030769 ↗InjuryJul 27, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50030765 ↗InjuryJul 27, 2026Osseointegration Problem
Primary stability couldn¿t be achieve.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50027586 ↗InjuryJul 27, 2026Osseointegration Problem
Primary stability couldn¿t be achieved.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50027472 ↗InjuryJul 27, 2026Loss of Osseointegration
InjuryJul 27, 2026Loss of Osseointegration
InjuryJul 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25863702 ↗InjuryJul 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25863700 ↗
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.
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