NobelReplace® Conical Connection TiUltra™ 300337Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection TiUltra™ NP 3.5x8mm · Class 2 · Implant
All models of NobelReplace Conical Connection TiUltra (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare NobelReplace dental implant is a root-form implant placed in the jawbone. The 1,496 reports most often describe the implant failing to bond with the jawbone or losing that bond, and patients mention implant failure, infection, pain and inflammation. The reports list no deaths and 1,476 injuries. 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
- 1,513
- Deaths reported
- 0
- Injuries reported
- 1,493
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,513 adverse event reports that list this exact device (DI 07332747128284), received between Nov 8, 2021 and Sep 30, 2026 — classified as 1,493 injuries, 20 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,122 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 Osseointegrate1,122
- Loss of Osseointegration222
- Osseointegration Problem81
- Adverse Event Without Identified Device or Use Problem30
- Patient Device Interaction Problem14
- Difficult to Insert10
- Fracture8
- Insufficient Device Problem Information8
Patient problems
- Failure of Implant924
- No Clinical Signs, Symptoms or Conditions490
- Unspecified Infection80
- Pain44
- Inflammation30
- Implant Pain18
- Abscess16
- Sinus Perforation10
Recent adverse event reports
The 25 most recent of 1,513 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 50954486 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954479 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954204 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954201 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940020 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940017 ↗InjurySep 18, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830368 ↗InjurySep 18, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830365 ↗InjurySep 9, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50701222 ↗InjurySep 9, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50701219 ↗InjurySep 8, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50677640 ↗InjurySep 8, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50677639 ↗InjuryAug 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486700 ↗InjuryAug 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486685 ↗InjuryAug 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486451 ↗InjuryAug 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486450 ↗InjuryAug 26, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50463506 ↗InjuryAug 26, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50463504 ↗InjuryAug 22, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50392480 ↗InjuryAug 21, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50382471 ↗InjuryAug 19, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50333019 ↗InjuryAug 19, 2026Failure to Osseointegrate
InjuryAug 19, 2026Failure to Osseointegrate
InjuryAug 12, 2026Loss of Osseointegration
InjuryAug 12, 2026Loss of Osseointegration
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