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Replace Select™ 37306 (UDI 07332747160864)Recalls & reported problems

Nobel Biocare AB · Replace Select™ Tapered PMC RP 4.3x10mm · Class 2 · Implant

Quick summary

This Nobel Biocare Replace Select dental implant has 1,902 adverse event reports on record, with no deaths and 1,881 injuries. Most reports describe the implant failing to bond with the jawbone (osseointegration), with some describing loss of that bond, fractures, pain and 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
1,910
Deaths reported
0
Injuries reported
1,889
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1,910 adverse event reports that list this exact device (DI 07332747160864), received between Oct 29, 2021 and Sep 30, 2026 — classified as 1,889 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (1,195 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: 52 reportsDec 2023: 20 reportsJan 2024: 42 reportsFeb 2024: 16 reportsMar 2024: 48 reportsApr 2024: 28 reportsMay 2024: 54 reportsJun 2024: 22 reportsJul 2024: 54 reportsAug 2024: 30 reportsSep 2024: 32 reportsOct 2024: 52 reportsNov 2024: 28 reportsDec 2024: 16 reportsJan 2025: 22 reportsFeb 2025: 34 reportsMar 2025: 24 reportsApr 2025: 4 reportsMay 2025: 0 reportsJun 2025: 2 reportsJul 2025: 100 reportsAug 2025: 18 reportsSep 2025: 8 reportsOct 2025: 18 reportsNov 2025: 24 reportsDec 2025: 20 reportsJan 2026: 20 reportsFeb 2026: 42 reportsMar 2026: 30 reportsApr 2026: 24 reportsMay 2026: 20 reportsJun 2026: 20 reportsJul 2026: 26 reportsAug 2026: 23 reportsSep 2026: 10 reportsOct 2026: 0 reports202420252026100
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Osseointegrate1,195
  • Loss of Osseointegration456
  • Osseointegration Problem119
  • Adverse Event Without Identified Device or Use Problem42
  • Fracture38
  • Insufficient Device Problem Information18
  • Patient Device Interaction Problem14
  • Migration10

Patient problems

  • Failure of Implant1,473
  • Pain265
  • No Clinical Signs, Symptoms or Conditions262
  • Unspecified Infection233
  • Numbness48
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available38
  • Abscess20
  • Inflammation14

Recent adverse event reports

The 25 most recent of 1,910 reports, in the reporter's own words as published by the FDA.

  • InjurySep 30, 2026Failure to Osseointegrate

    Patient problems: Abscess

    MAUDE report 50954293 ↗
  • InjurySep 30, 2026Failure to Osseointegrate

    Patient problems: Abscess

    MAUDE report 50954291 ↗
  • InjurySep 30, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50953327 ↗
  • InjurySep 30, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50953326 ↗
  • InjurySep 28, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50925320 ↗
  • InjurySep 28, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50925318 ↗
  • InjurySep 14, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50748513 ↗
  • InjurySep 14, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50748511 ↗
  • InjurySep 14, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50748481 ↗
  • InjurySep 14, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50748478 ↗
  • InjuryAug 27, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50487053 ↗
  • InjuryAug 27, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50487042 ↗
  • InjuryAug 27, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50487028 ↗
  • InjuryAug 27, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50487025 ↗
  • InjuryAug 27, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50487009 ↗
  • InjuryAug 27, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50487004 ↗
  • InjuryAug 27, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50486923 ↗
  • InjuryAug 27, 2026Failure to Osseointegrate

    Failure to Osseo integrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50486918 ↗
  • InjuryAug 27, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50486890 ↗
  • InjuryAug 27, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50486888 ↗
  • InjuryAug 27, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50486874 ↗
  • InjuryAug 27, 2026Failure to Osseointegrate

    Failure to Osseo integrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50486873 ↗
  • InjuryAug 20, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50358700 ↗
  • InjuryAug 20, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50358698 ↗
  • InjuryAug 19, 2026Loss of Osseointegration

    Loss of osseointegration.

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

    MAUDE report 50331861 ↗

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.