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NobelParallel™ Conical Connection TiUltra™ 300309Recalls & reported problems

Nobel Biocare AB · NobelParallel™ Conical Connection TiUltra™ RP 5.0 x7mm · Class 2 · Implant

All models of NobelParallel Conical Connection TiUltra (27)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Nobel Biocare NobelParallel TiUltra implant is a screw-shaped device placed into bone. The 998 reports mostly describe the implant failing to bond with the bone, with some patients reporting numbness, pain or infection. There are 991 injury reports, 7 malfunction reports 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
1,008
Deaths reported
0
Injuries reported
1,001
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1,008 adverse event reports that list this exact device (DI 07332747128017), received between Oct 29, 2021 and Sep 29, 2026 — classified as 1,001 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (647 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

Nov 2023: 20 reportsDec 2023: 18 reportsJan 2024: 14 reportsFeb 2024: 18 reportsMar 2024: 24 reportsApr 2024: 40 reportsMay 2024: 14 reportsJun 2024: 26 reportsJul 2024: 18 reportsAug 2024: 9 reportsSep 2024: 32 reportsOct 2024: 20 reportsNov 2024: 22 reportsDec 2024: 9 reportsJan 2025: 32 reportsFeb 2025: 14 reportsMar 2025: 38 reportsApr 2025: 2 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 72 reportsAug 2025: 22 reportsSep 2025: 24 reportsOct 2025: 12 reportsNov 2025: 30 reportsDec 2025: 24 reportsJan 2026: 8 reportsFeb 2026: 14 reportsMar 2026: 34 reportsApr 2026: 34 reportsMay 2026: 18 reportsJun 2026: 17 reportsJul 2026: 12 reportsAug 2026: 14 reportsSep 2026: 10 reportsOct 2026: 0 reports20242025202672
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Osseointegrate647
  • Loss of Osseointegration239
  • Osseointegration Problem72
  • Patient Device Interaction Problem14
  • Adverse Event Without Identified Device or Use Problem10
  • Migration8
  • Activation, Positioning or Separation Problem4
  • Difficult to Insert4

Patient problems

  • Failure of Implant642
  • No Clinical Signs, Symptoms or Conditions263
  • Pain60
  • Unspecified Infection59
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available26
  • Numbness20
  • Implant Pain18
  • Inflammation16

Recent adverse event reports

The 25 most recent of 1,008 reports, in the reporter's own words as published by the FDA.

  • InjurySep 29, 2026Failure to Osseointegrate

    Patient problems: Inflammation

    MAUDE report 50940622 ↗
  • InjurySep 29, 2026Failure to Osseointegrate

    Patient problems: Inflammation

    MAUDE report 50940614 ↗
  • InjurySep 29, 2026Failure to Osseointegrate

    Patient problems: Unspecified Infection

    MAUDE report 50940563 ↗
  • InjurySep 29, 2026Failure to Osseointegrate

    Patient problems: Unspecified Infection

    MAUDE report 50940561 ↗
  • InjurySep 11, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50743449 ↗
  • InjurySep 11, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50743447 ↗
  • InjurySep 9, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50700290 ↗
  • InjurySep 9, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50700287 ↗
  • InjurySep 7, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50657538 ↗
  • InjurySep 7, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50657536 ↗
  • InjuryAug 18, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50310811 ↗
  • InjuryAug 18, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50310806 ↗
  • InjuryAug 14, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50262407 ↗
  • InjuryAug 14, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50262406 ↗
  • InjuryAug 7, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50183623 ↗
  • InjuryAug 7, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50183622 ↗
  • InjuryAug 7, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: Unspecified Infection

    MAUDE report 50183406 ↗
  • InjuryAug 7, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: Unspecified Infection

    MAUDE report 50183403 ↗
  • InjuryAug 7, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50183353 ↗
  • InjuryAug 7, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50183349 ↗
  • InjuryAug 6, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 50168021 ↗
  • InjuryAug 6, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

    MAUDE report 50168018 ↗
  • InjuryAug 4, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: Inflammation

    MAUDE report 50135221 ↗
  • InjuryAug 4, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: Inflammation

    MAUDE report 50135219 ↗
  • InjuryJul 29, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50076851 ↗

Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices

All IMPLANT, ENDOSSEOUS, ROOT-FORM devices →

Sources and updates

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