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NobelActive® 37808 (UDI 07332747161144)Recalls & reported problems

Nobel Biocare AB · NobelActive® WP 5.5x10mm · Class 2 · Implant

Quick summary

This NobelActive implant is a root-form device placed in bone. Its 3,064 adverse event reports mostly describe implants that fail to fuse with the bone or lose that bond, and some mention migration, infection and pain. The reports include no deaths and 3,035 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
3,106
Deaths reported
0
Injuries reported
3,077
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3,106 adverse event reports that list this exact device (DI 07332747161144), received between Oct 29, 2021 and Sep 29, 2026 — classified as 3,077 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (1,851 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: 74 reportsDec 2023: 54 reportsJan 2024: 64 reportsFeb 2024: 56 reportsMar 2024: 52 reportsApr 2024: 58 reportsMay 2024: 28 reportsJun 2024: 56 reportsJul 2024: 36 reportsAug 2024: 40 reportsSep 2024: 70 reportsOct 2024: 48 reportsNov 2024: 52 reportsDec 2024: 24 reportsJan 2025: 54 reportsFeb 2025: 43 reportsMar 2025: 68 reportsApr 2025: 22 reportsMay 2025: 0 reportsJun 2025: 4 reportsJul 2025: 202 reportsAug 2025: 74 reportsSep 2025: 54 reportsOct 2025: 48 reportsNov 2025: 60 reportsDec 2025: 46 reportsJan 2026: 46 reportsFeb 2026: 66 reportsMar 2026: 47 reportsApr 2026: 48 reportsMay 2026: 32 reportsJun 2026: 31 reportsJul 2026: 46 reportsAug 2026: 50 reportsSep 2026: 34 reportsOct 2026: 0 reports202420252026202
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Osseointegrate1,851
  • Loss of Osseointegration790
  • Osseointegration Problem196
  • Migration59
  • Adverse Event Without Identified Device or Use Problem44
  • Insufficient Device Problem Information42
  • Patient Device Interaction Problem40
  • Fracture22

Patient problems

  • Failure of Implant2,118
  • No Clinical Signs, Symptoms or Conditions742
  • Unspecified Infection248
  • Pain198
  • Implant Pain40
  • Inflammation40
  • Insufficient Information38
  • Abscess36

Recent adverse event reports

The 25 most recent of 3,106 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 50940713 ↗
  • InjurySep 29, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50940710 ↗
  • InjurySep 19, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50833454 ↗
  • InjurySep 19, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50833453 ↗
  • InjurySep 18, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50830666 ↗
  • InjurySep 18, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50830665 ↗
  • InjurySep 18, 2026Osseointegration Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50829799 ↗
  • InjurySep 18, 2026Osseointegration Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50829795 ↗
  • InjurySep 16, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50796156 ↗
  • InjurySep 16, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50796154 ↗
  • InjurySep 16, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50796128 ↗
  • InjurySep 16, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50796122 ↗
  • InjurySep 16, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50796101 ↗
  • InjurySep 16, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50796100 ↗
  • InjurySep 15, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50780450 ↗
  • InjurySep 15, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50780449 ↗
  • InjurySep 15, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50780434 ↗
  • InjurySep 15, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50780433 ↗
  • InjurySep 14, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50749122 ↗
  • InjurySep 14, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50749119 ↗
  • InjurySep 11, 2026Osseointegration Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50743784 ↗
  • InjurySep 11, 2026Osseointegration Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50743781 ↗
  • InjurySep 11, 2026Osseointegration Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50743644 ↗
  • InjurySep 11, 2026Osseointegration Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50743642 ↗
  • InjurySep 10, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50724021 ↗

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.