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NobelActive® 37810 (UDI 07332747161168)Recalls & reported problems

Nobel Biocare AB · NobelActive® WP 5.5x13mm · Class 2 · Implant

All models of NobelActive (56)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Quick summary

This Nobel Biocare NobelActive dental implant is placed in the jawbone. Of its 566 reports, 556 are injuries and 10 describe malfunctions, most describing the implant failing to bond with the bone or losing that bond. Patients mention infection in 34 reports and numbness in 6, and some recent reports describe lack of stability during placement. There were no deaths, and 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
573
Deaths reported
0
Injuries reported
563
Recalls naming it
0

Summary

The FDA's MAUDE database contains 573 adverse event reports that list this exact device (DI 07332747161168), received between Nov 9, 2021 and Sep 30, 2026 — classified as 563 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (376 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

Nov 2023: 20 reportsDec 2023: 4 reportsJan 2024: 8 reportsFeb 2024: 18 reportsMar 2024: 8 reportsApr 2024: 10 reportsMay 2024: 10 reportsJun 2024: 4 reportsJul 2024: 6 reportsAug 2024: 2 reportsSep 2024: 12 reportsOct 2024: 9 reportsNov 2024: 4 reportsDec 2024: 4 reportsJan 2025: 2 reportsFeb 2025: 7 reportsMar 2025: 12 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 32 reportsAug 2025: 10 reportsSep 2025: 6 reportsOct 2025: 8 reportsNov 2025: 14 reportsDec 2025: 10 reportsJan 2026: 6 reportsFeb 2026: 20 reportsMar 2026: 14 reportsApr 2026: 18 reportsMay 2026: 6 reportsJun 2026: 8 reportsJul 2026: 6 reportsAug 2026: 7 reportsSep 2026: 6 reportsOct 2026: 0 reports20242025202632
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Osseointegrate376
  • Loss of Osseointegration96
  • Osseointegration Problem43
  • Patient Device Interaction Problem14
  • Adverse Event Without Identified Device or Use Problem10
  • Insufficient Device Problem Information8
  • Difficult to Insert6
  • Migration6

Patient problems

  • Failure of Implant380
  • No Clinical Signs, Symptoms or Conditions151
  • Unspecified Infection34
  • Pain32
  • Insufficient Information8
  • Numbness6
  • Bone Fracture(s)4
  • Inflammation4

Recent adverse event reports

The 25 most recent of 573 reports, in the reporter's own words as published by the FDA.

  • InjurySep 30, 2026Osseointegration Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50953067 ↗
  • InjurySep 30, 2026Osseointegration Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50953066 ↗
  • InjurySep 18, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50830700 ↗
  • InjurySep 18, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50830699 ↗
  • InjurySep 7, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50657451 ↗
  • InjurySep 7, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50657447 ↗
  • InjuryAug 19, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50333037 ↗
  • InjuryAug 19, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50332947 ↗
  • InjuryAug 19, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50332944 ↗
  • InjuryAug 5, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: Unspecified Infection

    MAUDE report 50149366 ↗
  • InjuryAug 5, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: Unspecified Infection

    MAUDE report 50149364 ↗
  • InjuryAug 3, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50110849 ↗
  • InjuryAug 3, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50110845 ↗
  • InjuryJul 16, 2026Osseointegration Problem

    LACK OF STABILITY DURING PLACEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25848997 ↗
  • InjuryJul 16, 2026Osseointegration Problem

    LACK OF STABILITY DURING PLACEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25848993 ↗
  • InjuryJul 3, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25708616 ↗
  • InjuryJul 3, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25708580 ↗
  • InjuryJul 1, 2026Osseointegration Problem

    LACK OF STABILITY DURING PLACEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25684191 ↗
  • InjuryJul 1, 2026Osseointegration Problem

    LACK OF STABILITY DURING PLACEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25684189 ↗
  • InjuryJun 26, 2026Osseointegration Problem

    LACK OF STABILITY DURING PLACEMENT.

    Patient problems: Bone Fracture(s)

    MAUDE report 25643437 ↗
  • InjuryJun 26, 2026Osseointegration Problem

    LACK OF STABILITY DURING PLACEMENT.

    Patient problems: Bone Fracture(s)

    MAUDE report 25643435 ↗
  • InjuryJun 16, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25525782 ↗
  • InjuryJun 16, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25525781 ↗
  • InjuryJun 11, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25479555 ↗
  • InjuryJun 11, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25479554 ↗

Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices

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Sources and updates

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