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NobelReplace® 36699 (UDI 07332747035773)Recalls & reported problems

Nobel Biocare AB · NobelReplace® Conical Connection NP 3.5x8mm · Class 2 · Implant

Quick summary

This Nobel Biocare NobelReplace dental implant appears in 870 adverse event reports, with 862 injuries and no deaths. Most describe the implant failing to fuse with the surrounding bone, and some mention pain, numbness or infection. 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
873
Deaths reported
0
Injuries reported
865
Recalls naming it
0

Summary

The FDA's MAUDE database contains 873 adverse event reports that list this exact device (DI 07332747035773), received between Sep 11, 2019 and Aug 19, 2026 — classified as 865 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (438 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: 20 reportsDec 2023: 20 reportsJan 2024: 15 reportsFeb 2024: 11 reportsMar 2024: 5 reportsApr 2024: 17 reportsMay 2024: 24 reportsJun 2024: 34 reportsJul 2024: 8 reportsAug 2024: 2 reportsSep 2024: 4 reportsOct 2024: 6 reportsNov 2024: 26 reportsDec 2024: 14 reportsJan 2025: 20 reportsFeb 2025: 2 reportsMar 2025: 6 reportsApr 2025: 2 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 20 reportsAug 2025: 4 reportsSep 2025: 4 reportsOct 2025: 0 reportsNov 2025: 4 reportsDec 2025: 10 reportsJan 2026: 26 reportsFeb 2026: 10 reportsMar 2026: 4 reportsApr 2026: 2 reportsMay 2026: 4 reportsJun 2026: 2 reportsJul 2026: 6 reportsAug 2026: 2 reportsSep 2026: 0 reportsOct 2026: 0 reports20242025202634
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Osseointegrate438
  • Loss of Osseointegration378
  • Osseointegration Problem26
  • Adverse Event Without Identified Device or Use Problem12
  • Migration7
  • Fracture4
  • Insufficient Device Problem Information3
  • Patient Device Interaction Problem2

Patient problems

  • Failure of Implant762
  • Pain114
  • No Clinical Signs, Symptoms or Conditions77
  • Unspecified Infection53
  • Numbness20
  • Inflammation6
  • Foreign Body In Patient5
  • Fistula4

Recent adverse event reports

The 25 most recent of 873 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 19, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: Unspecified Infection

    MAUDE report 50332479 ↗
  • InjuryAug 19, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: Unspecified Infection

    MAUDE report 50332477 ↗
  • InjuryJul 31, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: Fistula

    MAUDE report 50106201 ↗
  • InjuryJul 31, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: Fistula

    MAUDE report 50106199 ↗
  • InjuryJul 29, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50076943 ↗
  • InjuryJul 29, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50076934 ↗
  • InjuryJul 7, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25740846 ↗
  • InjuryJul 7, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25740845 ↗
  • InjuryJun 16, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Fistula

    MAUDE report 25526090 ↗
  • InjuryJun 16, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Fistula

    MAUDE report 25526070 ↗
  • InjuryMay 27, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25310097 ↗
  • InjuryMay 27, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25310051 ↗
  • InjuryMay 22, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25262470 ↗
  • InjuryMay 22, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25262406 ↗
  • InjuryApr 28, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25022828 ↗
  • InjuryApr 28, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25022743 ↗
  • InjuryMar 20, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24655125 ↗
  • InjuryMar 20, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24655063 ↗
  • InjuryMar 18, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24632692 ↗
  • InjuryMar 18, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24632683 ↗
  • InjuryFeb 24, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24435163 ↗
  • InjuryFeb 24, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24435159 ↗
  • InjuryFeb 19, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24396159 ↗
  • InjuryFeb 19, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24396158 ↗
  • InjuryFeb 19, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24394614 ↗

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.