NobelReplace® Conical Connection TiUltra™ 300349Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection TiUltra™ RP 5.0x11.5mm · 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 placed in the jawbone to hold a replacement tooth. Reports mostly describe implants that failed to fuse with the bone or lost that bond, and some mention infection, pain or numbness. There are 905 reports, no deaths and 892 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
- 930
- Deaths reported
- 0
- Injuries reported
- 917
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 930 adverse event reports that list this exact device (DI 07332747128451), received between Oct 29, 2021 and Sep 29, 2026 — classified as 917 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (628 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 Osseointegrate628
- Loss of Osseointegration146
- Osseointegration Problem74
- Adverse Event Without Identified Device or Use Problem27
- Patient Device Interaction Problem20
- Difficult to Insert14
- Insufficient Device Problem Information6
- Migration6
Patient problems
- Failure of Implant591
- No Clinical Signs, Symptoms or Conditions258
- Unspecified Infection83
- Pain55
- Numbness12
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available10
- Inflammation8
- Bone Fracture(s)6
Recent adverse event reports
The 25 most recent of 930 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 50940578 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940576 ↗InjurySep 19, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833468 ↗InjurySep 19, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833467 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811620 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50811618 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Inflammation
MAUDE report 50811393 ↗InjurySep 17, 2026Failure to Osseointegrate
Patient problems: Inflammation
MAUDE report 50811391 ↗InjurySep 16, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796158 ↗InjurySep 16, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796157 ↗InjurySep 16, 2026Failure to Osseointegrate
Failure to osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795110 ↗InjurySep 16, 2026Failure to Osseointegrate
Failure to osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795108 ↗InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749085 ↗InjurySep 14, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50749081 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724288 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724283 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724153 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724147 ↗InjurySep 8, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50679073 ↗InjurySep 8, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50679069 ↗InjuryAug 26, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50463457 ↗InjuryAug 26, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50463455 ↗InjuryAug 26, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50463375 ↗InjuryAug 26, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50463374 ↗InjuryAug 19, 2026Failure to Osseointegrate
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