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NobelReplace® 36702 (UDI 07332747035742)Recalls & reported problems

Nobel Biocare AB · NobelReplace® Conical Connection NP 3.5x13mm · Class 2 · Implant

Quick summary

This NobelReplace dental implant is placed into bone to support a replacement tooth. The 956 reports mostly describe the implant failing to bond with the bone or losing that bond later, and mention pain and infections. The reports include no deaths and 951 injuries, 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
957
Deaths reported
0
Injuries reported
952
Recalls naming it
0

Summary

The FDA's MAUDE database contains 957 adverse event reports that list this exact device (DI 07332747035742), received between Apr 30, 2019 and Sep 29, 2026 — classified as 952 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (460 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: 16 reportsDec 2023: 10 reportsJan 2024: 10 reportsFeb 2024: 15 reportsMar 2024: 14 reportsApr 2024: 25 reportsMay 2024: 32 reportsJun 2024: 14 reportsJul 2024: 0 reportsAug 2024: 6 reportsSep 2024: 0 reportsOct 2024: 8 reportsNov 2024: 10 reportsDec 2024: 4 reportsJan 2025: 12 reportsFeb 2025: 6 reportsMar 2025: 4 reportsApr 2025: 2 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 12 reportsAug 2025: 8 reportsSep 2025: 6 reportsOct 2025: 0 reportsNov 2025: 2 reportsDec 2025: 12 reportsJan 2026: 6 reportsFeb 2026: 20 reportsMar 2026: 4 reportsApr 2026: 4 reportsMay 2026: 12 reportsJun 2026: 0 reportsJul 2026: 12 reportsAug 2026: 8 reportsSep 2026: 2 reportsOct 2026: 0 reports20242025202632
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Osseointegrate460
  • Loss of Osseointegration448
  • Osseointegration Problem23
  • Fracture13
  • Adverse Event Without Identified Device or Use Problem10
  • Migration4
  • Insufficient Device Problem Information2
  • Premature Separation2

Patient problems

  • Failure of Implant848
  • Pain126
  • No Clinical Signs, Symptoms or Conditions88
  • Unspecified Infection87
  • Numbness21
  • Implant Pain6
  • Bone Fracture(s)3
  • Abscess2

Recent adverse event reports

The 25 most recent of 957 reports, in the reporter's own words as published by the FDA.

  • InjurySep 29, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50939558 ↗
  • InjurySep 29, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50939556 ↗
  • InjuryAug 25, 2026Loss of Osseointegration

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

    MAUDE report 50440319 ↗
  • InjuryAug 25, 2026Loss of Osseointegration

    Loss of osseointegration.

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

    MAUDE report 50440317 ↗
  • InjuryAug 13, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50243392 ↗
  • InjuryAug 13, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50243389 ↗
  • InjuryAug 3, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50111030 ↗
  • InjuryAug 3, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50111028 ↗
  • InjuryAug 3, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50111020 ↗
  • InjuryAug 3, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50111019 ↗
  • InjuryJul 30, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50093307 ↗
  • InjuryJul 30, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50093301 ↗
  • InjuryJul 27, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50014711 ↗
  • InjuryJul 27, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50014710 ↗
  • InjuryJul 17, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25862507 ↗
  • InjuryJul 17, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25862504 ↗
  • InjuryJul 17, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: Unspecified Infection

    MAUDE report 25862387 ↗
  • InjuryJul 17, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: Unspecified Infection

    MAUDE report 25862382 ↗
  • InjuryJul 13, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25807189 ↗
  • InjuryJul 13, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25807188 ↗
  • InjuryJul 8, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25755003 ↗
  • InjuryJul 8, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25754946 ↗
  • InjuryMay 27, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25309823 ↗
  • InjuryMay 27, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25309788 ↗
  • InjuryMay 15, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25194361 ↗

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.