NobelReplace® Conical Connection TiUltra™ 300350Recalls & reported problems
Nobel Biocare AB · NobelReplace® Conical Connection TiUltra™ RP 5.0x13mm · Class 2 · Implant
All models of NobelReplace Conical Connection TiUltra (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare NobelReplace dental implant has 421 reports, including 420 injuries and no deaths. Most reports describe the implant failing to bond with the jawbone, and some describe abscesses or bone fractures. 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
- 429
- Deaths reported
- 0
- Injuries reported
- 428
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 429 adverse event reports that list this exact device (DI 07332747128468), received between Nov 4, 2021 and Sep 29, 2026 — classified as 428 injuries, 1 malfunction.
The most frequently reported specific device problem is “Failure to Osseointegrate” (322 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 Osseointegrate322
- Osseointegration Problem49
- Loss of Osseointegration36
- Adverse Event Without Identified Device or Use Problem8
- Patient Device Interaction Problem8
- Activation, Positioning or Separation Problem2
- Difficult to Insert2
- Insufficient Device Problem Information2
Patient problems
- Failure of Implant256
- No Clinical Signs, Symptoms or Conditions147
- Unspecified Infection16
- Abscess10
- Pain10
- Bone Fracture(s)8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Numbness4
Recent adverse event reports
The 25 most recent of 429 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 50940234 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940225 ↗InjurySep 16, 2026Osseointegration Problem
Patient problems: Bone Fracture(s)
MAUDE report 50796172 ↗InjurySep 16, 2026Osseointegration Problem
Patient problems: Bone Fracture(s)
MAUDE report 50796170 ↗InjurySep 16, 2026Osseointegration Problem
Patient problems: Bone Fracture(s)
MAUDE report 50796147 ↗InjurySep 16, 2026Osseointegration Problem
Patient problems: Bone Fracture(s)
MAUDE report 50796143 ↗InjurySep 14, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764594 ↗InjurySep 14, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764592 ↗InjuryAug 25, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50441102 ↗InjuryAug 25, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50441099 ↗InjuryAug 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50262138 ↗InjuryAug 14, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50262135 ↗InjuryAug 13, 2026Failure to Osseointegrate
InjuryAug 13, 2026Failure to Osseointegrate
InjuryAug 13, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50243284 ↗InjuryAug 13, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50243269 ↗InjuryAug 6, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50167356 ↗InjuryAug 6, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50167352 ↗InjuryJul 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50030653 ↗InjuryJul 27, 2026Failure to Osseointegrate
Failure to osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50030652 ↗InjuryJul 27, 2026Failure to Osseointegrate
InjuryJul 27, 2026Failure to Osseointegrate
InjuryJul 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50013216 ↗InjuryJul 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50013213 ↗InjuryJul 14, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25819717 ↗
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- 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 13, 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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