NobelReplace® Conical Connection TiUltra™ 300341Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection TiUltra™ NP 3.5x16mm · 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 TiUltra dental implant is a post placed in the jawbone to hold a tooth replacement. Its 333 reports mostly describe the implant failing to bond with the jawbone, sometimes lacking stability during placement. The reports mention 331 injuries 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
- 336
- Deaths reported
- 0
- Injuries reported
- 334
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 336 adverse event reports that list this exact device (DI 07332747128314), received between Dec 9, 2021 and Sep 14, 2026 — classified as 334 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (220 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 Osseointegrate220
- Loss of Osseointegration38
- Osseointegration Problem34
- Fracture12
- Patient Device Interaction Problem10
- Adverse Event Without Identified Device or Use Problem6
- Activation, Positioning or Separation Problem4
- Insufficient Device Problem Information4
Patient problems
- Failure of Implant200
- No Clinical Signs, Symptoms or Conditions120
- Unspecified Infection18
- Pain14
- Numbness8
- Fistula4
- Insufficient Information4
- Abscess2
Recent adverse event reports
The 25 most recent of 336 reports, in the reporter's own words as published by the FDA.
InjurySep 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748885 ↗InjurySep 14, 2026Failure to Osseointegrate
Failure to Osseo integrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748884 ↗InjuryAug 20, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50357447 ↗InjuryAug 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50262168 ↗InjuryAug 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50262160 ↗InjuryAug 11, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50214776 ↗InjuryAug 11, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50214775 ↗InjuryAug 6, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50167331 ↗InjuryAug 6, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50167321 ↗InjuryJul 2, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25697803 ↗InjuryJul 2, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25697796 ↗InjuryJun 27, 2026Failure to Osseointegrate
InjuryJun 27, 2026Failure to Osseointegrate
InjuryJun 5, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25417808 ↗InjuryJun 5, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25416799 ↗InjuryJun 5, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25416630 ↗InjuryJun 5, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25416436 ↗InjuryJun 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25384563 ↗InjuryJun 3, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25384556 ↗InjuryJun 3, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25383971 ↗InjuryJun 3, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25383962 ↗InjuryMay 16, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25195679 ↗InjuryMay 16, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25195676 ↗InjuryMay 14, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25178108 ↗InjuryMay 14, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25178105 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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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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