NobelReplace® Conical Connection TiUltra™ 300347Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection TiUltra™ RP 5.0x8mm · 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 has 2,213 reports, with 2,203 listed as injuries and no deaths. Most describe the implant failing to osseointegrate, or losing its bond with the jawbone. Some reports also mention infection, pain and a sinus perforation. 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
- 2,248
- Deaths reported
- 0
- Injuries reported
- 2,238
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2,248 adverse event reports that list this exact device (DI 07332747128383), received between Nov 4, 2021 and Sep 30, 2026 — classified as 2,238 injuries, 10 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,681 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 Osseointegrate1,681
- Loss of Osseointegration343
- Osseointegration Problem116
- Adverse Event Without Identified Device or Use Problem34
- Patient Device Interaction Problem26
- Malposition of Device12
- Difficult to Insert6
- Migration6
Patient problems
- Failure of Implant1,368
- No Clinical Signs, Symptoms or Conditions667
- Unspecified Infection182
- Pain71
- Inflammation36
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available24
- Sinus Perforation24
- Abscess19
Recent adverse event reports
The 25 most recent of 2,248 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 50953803 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953802 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: Sinus Perforation
MAUDE report 50833623 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: Sinus Perforation
MAUDE report 50833619 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833518 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833514 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833506 ↗InjurySep 19, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50833504 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830619 ↗InjurySep 18, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830617 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50764727 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50764724 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743537 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743536 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743347 ↗InjurySep 11, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743345 ↗InjurySep 10, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50724367 ↗InjurySep 10, 2026Loss of Osseointegration
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50724365 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50724354 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50724351 ↗InjurySep 10, 2026Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50723614 ↗InjurySep 10, 2026Migration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50723609 ↗InjurySep 9, 2026Loss of Osseointegration
Patient problems: Inflammation
MAUDE report 50701185 ↗InjurySep 9, 2026Loss of Osseointegration
Patient problems: Inflammation
MAUDE report 50701167 ↗InjuryAug 27, 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.
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