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Replace Select™ 29413 (UDI 07332747000139)Recalls & reported problems

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

Quick summary

This Nobel Biocare Replace Select dental implant has 2,136 reports, with 2,130 listed as injuries and no deaths. Most describe the implant losing its bond with the jawbone, or failing to bond in the first place. Some reports also mention pain, infection and numbness. 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
2,142
Deaths reported
0
Injuries reported
2,136
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2,142 adverse event reports that list this exact device (DI 07332747000139), received between Nov 12, 2018 and Sep 17, 2026 — classified as 2,136 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (1,446 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: 55 reportsDec 2023: 35 reportsJan 2024: 30 reportsFeb 2024: 19 reportsMar 2024: 37 reportsApr 2024: 42 reportsMay 2024: 37 reportsJun 2024: 41 reportsJul 2024: 8 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 2 reportsNov 2024: 2 reportsDec 2024: 0 reportsJan 2025: 2 reportsFeb 2025: 2 reportsMar 2025: 2 reportsApr 2025: 2 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 6 reportsAug 2025: 6 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 6 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 4 reportsMar 2026: 2 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 2 reportsAug 2026: 0 reportsSep 2026: 6 reportsOct 2026: 0 reports20242025202655
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Loss of Osseointegration1,446
  • Failure to Osseointegrate547
  • Osseointegration Problem72
  • Fracture45
  • Adverse Event Without Identified Device or Use Problem27
  • Insufficient Device Problem Information4
  • Patient-Device Incompatibility4
  • Malposition of Device2

Patient problems

  • Failure of Implant2,096
  • Pain354
  • Unspecified Infection194
  • Numbness88
  • No Clinical Signs, Symptoms or Conditions28
  • Abscess9
  • Insufficient Information4
  • Nerve Damage4

Recent adverse event reports

The 25 most recent of 2,142 reports, in the reporter's own words as published by the FDA.

  • InjurySep 17, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50811840 ↗
  • InjurySep 17, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50811836 ↗
  • InjurySep 17, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50811835 ↗
  • InjurySep 17, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50811833 ↗
  • InjurySep 15, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50781019 ↗
  • InjurySep 15, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50781012 ↗
  • InjuryJul 27, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50030274 ↗
  • InjuryJul 27, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50030273 ↗
  • InjuryMar 24, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24677634 ↗
  • InjuryMar 24, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24677633 ↗
  • InjuryFeb 26, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Unspecified Infection

    MAUDE report 24462850 ↗
  • InjuryFeb 26, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Unspecified Infection

    MAUDE report 24462849 ↗
  • InjuryFeb 16, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24353553 ↗
  • InjuryFeb 16, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24353552 ↗
  • InjuryNov 28, 2025Loss of Osseointegration; Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Unspecified Infection

    MAUDE report 23675167 ↗
  • InjuryNov 28, 2025Loss of Osseointegration; Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Unspecified Infection

    MAUDE report 23675162 ↗
  • InjuryNov 26, 2025Loss of Osseointegration; Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23662574 ↗
  • InjuryNov 26, 2025Loss of Osseointegration; Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23662573 ↗
  • InjuryNov 22, 2025Failure to Osseointegrate; Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23626481 ↗
  • InjuryNov 22, 2025Failure to Osseointegrate; Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23626477 ↗
  • InjuryAug 8, 2025Loss of Osseointegration; Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22766183 ↗
  • InjuryAug 8, 2025Loss of Osseointegration; Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22766180 ↗
  • InjuryAug 1, 2025Loss of Osseointegration; Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22692683 ↗
  • InjuryAug 1, 2025Loss of Osseointegration; Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22692672 ↗
  • InjuryAug 1, 2025Loss of Osseointegration; Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22691565 ↗

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.