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NobelReplace® 36714 (UDI 07332747160598)Recalls & reported problems

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

Quick summary

This Nobel Biocare NobelReplace dental implant is a root-form implant placed in the jawbone. Its 92 reports, with 88 injuries and no deaths, mostly describe loss of osseointegration, meaning the implant does not bond with the jawbone, and a few describe infection or pain. 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
92
Deaths reported
0
Injuries reported
88
Recalls naming it
0

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 07332747160598), received between Nov 6, 2021 and Aug 27, 2026 — classified as 88 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (35 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: 1 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 1 reportsApr 2024: 5 reportsMay 2024: 4 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 2 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 2 reportsFeb 2025: 2 reportsMar 2025: 2 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 24 reportsAug 2025: 2 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 8 reportsJan 2026: 0 reportsFeb 2026: 2 reportsMar 2026: 0 reportsApr 2026: 4 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 2 reportsAug 2026: 8 reportsSep 2026: 0 reportsOct 2026: 0 reports20242025202624
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Loss of Osseointegration35
  • Failure to Osseointegrate30
  • Osseointegration Problem18
  • Adverse Event Without Identified Device or Use Problem3
  • Patient Device Interaction Problem2
  • Premature Separation2
  • Difficult to Insert1
  • Mechanical Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions46
  • Failure of Implant40
  • Unspecified Infection4
  • Pain3
  • Implant Pain2
  • Inflammation2
  • Bone Fracture(s)1

Recent adverse event reports

The 25 most recent of 92 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 27, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50487241 ↗
  • InjuryAug 27, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50487239 ↗
  • InjuryAug 13, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50243460 ↗
  • InjuryAug 13, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50243458 ↗
  • InjuryAug 12, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50229275 ↗
  • InjuryAug 12, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50229274 ↗
  • InjuryAug 12, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50229273 ↗
  • InjuryAug 12, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50229272 ↗
  • InjuryJul 17, 2026Osseointegration Problem

    LACK OF STABILITY DURING PLACEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25862804 ↗
  • InjuryJul 17, 2026Osseointegration Problem

    LACK OF STABILITY DURING PLACEMENT

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25862790 ↗
  • InjuryApr 11, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24848825 ↗
  • InjuryApr 10, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24841504 ↗
  • InjuryApr 9, 2026Osseointegration Problem

    PRIMARY STABILITY COULDN¿T BE ACHIEVE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24837322 ↗
  • InjuryApr 9, 2026Osseointegration Problem

    PRIMARY STABILITY COULDN¿T BE ACHIEVE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24837321 ↗
  • InjuryFeb 16, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: Implant Pain

    MAUDE report 24357298 ↗
  • InjuryFeb 16, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: Implant Pain

    MAUDE report 24357295 ↗
  • InjuryDec 31, 2025Osseointegration Problem; Osseointegration Problem

    LACK OF STABILITY DURING PLACEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23938454 ↗
  • InjuryDec 31, 2025Osseointegration Problem; Osseointegration Problem

    LACK OF STABILITY DURING PLACEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23938451 ↗
  • InjuryDec 20, 2025Osseointegration Problem; Osseointegration Problem

    LACK OF STABILITY DURING PLACEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23859879 ↗
  • InjuryDec 20, 2025Osseointegration Problem; Osseointegration Problem

    LACK OF STABILITY DURING PLACEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23859877 ↗
  • InjuryDec 3, 2025Failure to Osseointegrate; Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: Inflammation

    MAUDE report 23710703 ↗
  • InjuryDec 3, 2025Failure to Osseointegrate; Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: Inflammation

    MAUDE report 23710672 ↗
  • InjuryDec 3, 2025Osseointegration Problem; Osseointegration Problem

    LACK OF STABILITY DURING PLACEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23710605 ↗
  • InjuryDec 3, 2025Osseointegration Problem; Osseointegration Problem

    LACK OF STABILITY DURING PLACEMENT

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23710549 ↗
  • InjuryAug 21, 2025Osseointegration Problem; Osseointegration Problem

    LACK OF STABILITY DURING PLACEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22869265 ↗

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.