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NobelReplace® 36711 (UDI 07332747160567)Recalls & reported problems

Nobel Biocare AB · NobelReplace® Conical Connection RP 5.0x10mm · Class 2 · Implant

Quick summary

This Nobel Biocare NobelReplace dental implant is placed in the jawbone. The reports mostly describe implants that failed to bond with the bone, with some also mentioning infection, pain or inflammation. FDA records list 5,651 reports, no deaths, 5,606 injuries and 45 malfunctions. 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
5,742
Deaths reported
0
Injuries reported
5,697
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5,742 adverse event reports that list this exact device (DI 07332747160567), received between Oct 29, 2021 and Sep 29, 2026 — classified as 5,697 injuries, 45 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (4,074 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: 95 reportsDec 2023: 75 reportsJan 2024: 114 reportsFeb 2024: 52 reportsMar 2024: 107 reportsApr 2024: 130 reportsMay 2024: 84 reportsJun 2024: 108 reportsJul 2024: 87 reportsAug 2024: 93 reportsSep 2024: 135 reportsOct 2024: 150 reportsNov 2024: 122 reportsDec 2024: 108 reportsJan 2025: 158 reportsFeb 2025: 84 reportsMar 2025: 140 reportsApr 2025: 28 reportsMay 2025: 0 reportsJun 2025: 10 reportsJul 2025: 451 reportsAug 2025: 142 reportsSep 2025: 112 reportsOct 2025: 96 reportsNov 2025: 156 reportsDec 2025: 138 reportsJan 2026: 124 reportsFeb 2026: 142 reportsMar 2026: 110 reportsApr 2026: 170 reportsMay 2026: 150 reportsJun 2026: 117 reportsJul 2026: 113 reportsAug 2026: 122 reportsSep 2026: 82 reportsOct 2026: 0 reports202420252026451
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Osseointegrate4,074
  • Loss of Osseointegration1,139
  • Osseointegration Problem300
  • Adverse Event Without Identified Device or Use Problem66
  • Patient Device Interaction Problem39
  • Migration31
  • Difficult to Insert22
  • Fracture16

Patient problems

  • Failure of Implant3,434
  • No Clinical Signs, Symptoms or Conditions1,718
  • Unspecified Infection561
  • Pain238
  • Inflammation121
  • Implant Pain92
  • Abscess60
  • Numbness46

Recent adverse event reports

The 25 most recent of 5,742 reports, in the reporter's own words as published by the FDA.

  • InjurySep 29, 2026Osseointegration Problem

    Patient problems: Unspecified Infection

    MAUDE report 50940640 ↗
  • InjurySep 29, 2026Osseointegration Problem

    Patient problems: Unspecified Infection

    MAUDE report 50940638 ↗
  • InjurySep 29, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50940211 ↗
  • InjurySep 29, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50940210 ↗
  • InjurySep 29, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50940060 ↗
  • InjurySep 29, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50940058 ↗
  • InjurySep 29, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50939425 ↗
  • InjurySep 29, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50939424 ↗
  • InjurySep 29, 2026Osseointegration Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50939389 ↗
  • InjurySep 29, 2026Osseointegration Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50939386 ↗
  • InjurySep 29, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50939283 ↗
  • InjurySep 29, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50939281 ↗
  • InjurySep 29, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50939145 ↗
  • InjurySep 29, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50939143 ↗
  • InjurySep 29, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50939063 ↗
  • InjurySep 29, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50939060 ↗
  • InjurySep 28, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50924828 ↗
  • InjurySep 28, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50924824 ↗
  • InjurySep 28, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50924730 ↗
  • InjurySep 28, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50924725 ↗
  • InjurySep 28, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50924638 ↗
  • InjurySep 28, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50924637 ↗
  • InjurySep 28, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50924562 ↗
  • InjurySep 28, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50924555 ↗
  • InjurySep 27, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50910453 ↗

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.