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NobelActive® 36771 (UDI 07332747160628)Recalls & reported problems

Nobel Biocare AB · NobelActive® 3.0 3.0x13mm · Class 2 · Implant

Quick summary

This Nobel Biocare NobelActive dental implant is placed in the jawbone. Most of its 1,074 reports describe the implant failing to bond with the bone or losing that bond, and some mention pain, numbness or infection. The reports include no deaths and 1,058 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
1,076
Deaths reported
0
Injuries reported
1,060
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1,076 adverse event reports that list this exact device (DI 07332747160628), received between Nov 1, 2021 and Sep 19, 2026 — classified as 1,060 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (762 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: 24 reportsDec 2023: 24 reportsJan 2024: 24 reportsFeb 2024: 20 reportsMar 2024: 16 reportsApr 2024: 20 reportsMay 2024: 8 reportsJun 2024: 8 reportsJul 2024: 14 reportsAug 2024: 24 reportsSep 2024: 20 reportsOct 2024: 14 reportsNov 2024: 16 reportsDec 2024: 14 reportsJan 2025: 12 reportsFeb 2025: 16 reportsMar 2025: 15 reportsApr 2025: 10 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 42 reportsAug 2025: 12 reportsSep 2025: 10 reportsOct 2025: 22 reportsNov 2025: 26 reportsDec 2025: 24 reportsJan 2026: 14 reportsFeb 2026: 10 reportsMar 2026: 22 reportsApr 2026: 22 reportsMay 2026: 17 reportsJun 2026: 10 reportsJul 2026: 28 reportsAug 2026: 6 reportsSep 2026: 2 reportsOct 2026: 0 reports20242025202642
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Osseointegrate762
  • Loss of Osseointegration150
  • Osseointegration Problem63
  • Adverse Event Without Identified Device or Use Problem32
  • Fracture15
  • Patient Device Interaction Problem14
  • Insufficient Device Problem Information8
  • Migration8

Patient problems

  • Failure of Implant777
  • No Clinical Signs, Symptoms or Conditions219
  • Pain94
  • Unspecified Infection84
  • Numbness30
  • Abscess18
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available16
  • Bone Fracture(s)8

Recent adverse event reports

The 25 most recent of 1,076 reports, in the reporter's own words as published by the FDA.

  • InjurySep 19, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50833007 ↗
  • InjurySep 19, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50833006 ↗
  • InjuryAug 6, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50167747 ↗
  • InjuryAug 6, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50167746 ↗
  • InjuryAug 5, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: Unspecified Infection

    MAUDE report 50149437 ↗
  • InjuryAug 5, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: Unspecified Infection

    MAUDE report 50149431 ↗
  • InjuryAug 3, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50110816 ↗
  • InjuryAug 3, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50110815 ↗
  • InjuryJul 27, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50030809 ↗
  • InjuryJul 27, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50030808 ↗
  • InjuryJul 27, 2026Osseointegration Problem

    Lack of stability during placement.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50030567 ↗
  • InjuryJul 27, 2026Osseointegration Problem

    Lack of stability during placement.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50030566 ↗
  • InjuryJul 27, 2026Failure to Osseointegrate

    Failure to osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50027368 ↗
  • InjuryJul 27, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50027364 ↗
  • InjuryJul 27, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50014956 ↗
  • InjuryJul 27, 2026Failure to Osseointegrate

    Failure to osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50014955 ↗
  • InjuryJul 27, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50002952 ↗
  • InjuryJul 27, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50002951 ↗
  • InjuryJul 27, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50002947 ↗
  • InjuryJul 27, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50002946 ↗
  • InjuryJul 17, 2026Osseointegration Problem

    LACK OF STABILITY DURING PLACEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25863135 ↗
  • InjuryJul 17, 2026Osseointegration Problem

    LACK OF STABILITY DURING PLACEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25863119 ↗
  • InjuryJul 16, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

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

    MAUDE report 25849118 ↗
  • InjuryJul 16, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

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

    MAUDE report 25849115 ↗
  • InjuryJul 16, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25848878 ↗

Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices

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