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NobelReplace® 36714 (UDI 07332747035636)Recalls & reported problems

Nobel Biocare AB · NobelReplace® Conical Connection RP 5.0x16mm · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Quick summary

This Nobel Biocare NobelReplace implant is a dental implant placed into bone. Most of the 125 reports describe the implant failing to bond with the bone or losing that bond. The reports include no deaths and 121 injuries. Reports fell to 6 in the last 12 months from 24 in the previous 12. 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
125
Deaths reported
0
Injuries reported
121
Recalls naming it
0

Summary

The FDA's MAUDE database contains 125 adverse event reports that list this exact device (DI 07332747035636), received between Sep 11, 2019 and Apr 4, 2026 — classified as 121 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (76 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: 1 reportsDec 2023: 0 reportsJan 2024: 3 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 2 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 2 reportsOct 2024: 6 reportsNov 2024: 0 reportsDec 2024: 2 reportsJan 2025: 7 reportsFeb 2025: 7 reportsMar 2025: 4 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 4 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 2 reportsMar 2026: 0 reportsApr 2026: 4 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520267
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Osseointegrate76
  • Loss of Osseointegration39
  • Osseointegration Problem5
  • Adverse Event Without Identified Device or Use Problem3
  • Activation, Positioning or Separation Problem1
  • Migration1

Patient problems

  • Failure of Implant114
  • Pain8
  • No Clinical Signs, Symptoms or Conditions6
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
  • Numbness2
  • Unspecified Infection2
  • Abscess1
  • Foreign Body In Patient1

Recent adverse event reports

The 25 most recent of 125 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 4, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

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

    MAUDE report 24785953 ↗
  • InjuryApr 4, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

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

    MAUDE report 24785950 ↗
  • InjuryApr 4, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE

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

    MAUDE report 24785945 ↗
  • InjuryApr 4, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

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

    MAUDE report 24785942 ↗
  • InjuryFeb 3, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24253746 ↗
  • InjuryFeb 3, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24253738 ↗
  • InjuryJul 30, 2025Loss of Osseointegration; Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22671234 ↗
  • InjuryJul 30, 2025Loss of Osseointegration; Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22671225 ↗
  • InjuryJul 13, 2025Loss of Osseointegration; Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22491058 ↗
  • InjuryJul 13, 2025Loss of Osseointegration; Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22491055 ↗
  • InjuryMar 22, 2025Loss of Osseointegration; Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 21672878 ↗
  • InjuryMar 22, 2025Loss of Osseointegration; Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 21672874 ↗
  • InjuryMar 15, 2025Loss of Osseointegration; Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 21614708 ↗
  • InjuryMar 15, 2025Loss of Osseointegration; Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 21614707 ↗
  • InjuryFeb 13, 2025Failure to Osseointegrate; Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: Failure of Implant

    MAUDE report 21380123 ↗
  • InjuryFeb 13, 2025Failure to Osseointegrate; Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: Failure of Implant

    MAUDE report 21380120 ↗
  • InjuryFeb 13, 2025Failure to Osseointegrate; Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: Failure of Implant

    MAUDE report 21380101 ↗
  • InjuryFeb 13, 2025Failure to Osseointegrate; Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: Failure of Implant

    MAUDE report 21380096 ↗
  • InjuryFeb 7, 2025Loss of Osseointegration; Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 21339291 ↗
  • InjuryFeb 7, 2025Loss of Osseointegration; Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 21338745 ↗
  • InjuryFeb 4, 2025Failure to Osseointegrate; Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: Failure of Implant

    MAUDE report 21308031 ↗
  • InjuryJan 30, 2025Failure to Osseointegrate; Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: Failure of Implant

    MAUDE report 21278596 ↗
  • InjuryJan 30, 2025Failure to Osseointegrate; Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: Failure of Implant

    MAUDE report 21278595 ↗
  • InjuryJan 30, 2025Failure to Osseointegrate; Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: Failure of Implant

    MAUDE report 21278507 ↗
  • InjuryJan 30, 2025Failure to Osseointegrate; Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: Failure of Implant

    MAUDE report 21278506 ↗

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Sources and updates

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