NobelActive® TiUltra™ 300262Recalls & reported problems
Nobel Biocare AB · NobelActive® TiUltra™ WP 5.5x7mm · Class 2 · Implant
All models of NobelActive TiUltra (28)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare NobelActive TiUltra implant is a screw-shaped device placed into bone. The 1,002 reports mostly describe the implant failing to bond with the bone, with some patients reporting pain, infection or numbness. There are 990 injury reports, 12 malfunction reports and no deaths. 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
- 1,009
- Deaths reported
- 0
- Injuries reported
- 997
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,009 adverse event reports that list this exact device (DI 07332747127553), received between Nov 1, 2021 and Sep 29, 2026 — classified as 997 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (637 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate637
- Loss of Osseointegration232
- Osseointegration Problem64
- Adverse Event Without Identified Device or Use Problem24
- Patient Device Interaction Problem16
- Migration12
- Premature Separation8
- Fracture6
Patient problems
- Failure of Implant654
- No Clinical Signs, Symptoms or Conditions248
- Unspecified Infection125
- Pain88
- Numbness26
- Hypersensitivity/Allergic reaction16
- Inflammation12
- Fistula8
Recent adverse event reports
The 25 most recent of 1,009 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940265 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940264 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811677 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811670 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780768 ↗InjurySep 15, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780762 ↗InjurySep 14, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764516 ↗InjurySep 14, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764512 ↗InjuryAug 19, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50333139 ↗InjuryAug 14, 2026Failure to Osseointegrate
InjuryAug 14, 2026Failure to Osseointegrate
InjuryAug 13, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50243322 ↗InjuryAug 13, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50243318 ↗InjuryAug 13, 2026Loss of Osseointegration
InjuryAug 13, 2026Loss of Osseointegration
InjuryAug 13, 2026Failure to Osseointegrate
InjuryAug 13, 2026Failure to Osseointegrate
InjuryAug 13, 2026Failure to Osseointegrate
InjuryAug 13, 2026Failure to Osseointegrate
InjuryAug 13, 2026Failure to Osseointegrate
InjuryAug 13, 2026Failure to Osseointegrate
InjuryAug 13, 2026Failure to Osseointegrate
InjuryAug 13, 2026Failure to Osseointegrate
InjuryAug 13, 2026Failure to Osseointegrate
InjuryAug 13, 2026Failure to Osseointegrate
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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