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NobelParallel™ Conical Connection TiUltra™ 300305Recalls & reported problems

Nobel Biocare AB · NobelParallel™ Conical Connection TiUltra™ RP 4.3x11.5mm · Class 2 · Implant

Quick summary

This Nobel Biocare NobelParallel dental implant is placed in the jawbone. The reports mostly describe implants that failed to bond with the bone, with some also mentioning pain, infection or numbness. FDA records list 5,880 reports, no deaths, 5,801 injuries and 79 malfunctions. 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
5,907
Deaths reported
0
Injuries reported
5,828
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5,907 adverse event reports that list this exact device (DI 07332747127973), received between Oct 29, 2021 and Sep 30, 2026 — classified as 5,828 injuries, 79 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (4,290 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 140 reportsDec 2023: 76 reportsJan 2024: 90 reportsFeb 2024: 124 reportsMar 2024: 138 reportsApr 2024: 143 reportsMay 2024: 103 reportsJun 2024: 80 reportsJul 2024: 80 reportsAug 2024: 68 reportsSep 2024: 88 reportsOct 2024: 121 reportsNov 2024: 96 reportsDec 2024: 66 reportsJan 2025: 72 reportsFeb 2025: 117 reportsMar 2025: 122 reportsApr 2025: 32 reportsMay 2025: 1 reportsJun 2025: 10 reportsJul 2025: 410 reportsAug 2025: 124 reportsSep 2025: 62 reportsOct 2025: 64 reportsNov 2025: 100 reportsDec 2025: 98 reportsJan 2026: 60 reportsFeb 2026: 126 reportsMar 2026: 106 reportsApr 2026: 104 reportsMay 2026: 89 reportsJun 2026: 92 reportsJul 2026: 81 reportsAug 2026: 60 reportsSep 2026: 28 reportsOct 2026: 0 reports202420252026410
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Osseointegrate4,290
  • Loss of Osseointegration704
  • Osseointegration Problem453
  • Adverse Event Without Identified Device or Use Problem126
  • Patient Device Interaction Problem74
  • Fracture68
  • Premature Separation36
  • Activation, Positioning or Separation Problem24

Patient problems

  • Failure of Implant4,166
  • No Clinical Signs, Symptoms or Conditions1,208
  • Pain561
  • Unspecified Infection461
  • Implant Pain134
  • Numbness94
  • Abscess65
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available64

Recent adverse event reports

The 25 most recent of 5,907 reports, in the reporter's own words as published by the FDA.

  • InjurySep 30, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50953092 ↗
  • InjurySep 30, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50953088 ↗
  • InjurySep 19, 2026Failure to Osseointegrate

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

    MAUDE report 50833636 ↗
  • InjurySep 19, 2026Failure to Osseointegrate

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

    MAUDE report 50833631 ↗
  • InjurySep 19, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50833373 ↗
  • InjurySep 19, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50833368 ↗
  • InjurySep 19, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50833341 ↗
  • InjurySep 19, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50833340 ↗
  • InjurySep 18, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50830531 ↗
  • InjurySep 18, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50830530 ↗
  • InjurySep 17, 2026Osseointegration Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50811976 ↗
  • InjurySep 17, 2026Osseointegration Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50811968 ↗
  • InjurySep 15, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50781405 ↗
  • InjurySep 15, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50781400 ↗
  • InjurySep 15, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50780819 ↗
  • InjurySep 15, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50780817 ↗
  • InjurySep 14, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50764555 ↗
  • InjurySep 14, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50764553 ↗
  • InjurySep 11, 2026Osseointegration Problem

    Patient problems: Unspecified Infection

    MAUDE report 50743349 ↗
  • InjurySep 11, 2026Osseointegration Problem

    Patient problems: Unspecified Infection

    MAUDE report 50743346 ↗
  • InjurySep 11, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50743341 ↗
  • InjurySep 11, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50743338 ↗
  • InjurySep 10, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50723615 ↗
  • InjurySep 10, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50723611 ↗
  • InjurySep 10, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50723560 ↗

Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices

All IMPLANT, ENDOSSEOUS, ROOT-FORM devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.