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Replace Select™ 36289 (UDI 07332747160413)Recalls & reported problems

Nobel Biocare AB · Replace Select™ TC RP 4.0x(7+3)mm · Class 2 · Implant

All models of Replace Select (107)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
22
Deaths reported
0
Injuries reported
22
Recalls naming it
0

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07332747160413), received between Feb 10, 2023 and Aug 18, 2026 — classified as 22 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (16 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 4 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 4 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 2 reportsJul 2026: 2 reportsAug 2026: 4 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Osseointegrate16
  • Loss of Osseointegration6

Patient problems

  • Failure of Implant10
  • No Clinical Signs, Symptoms or Conditions6
  • Pain6
  • Implant Pain4
  • Unspecified Infection2

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 18, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50309786 ↗
  • InjuryAug 18, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50309776 ↗
  • InjuryAug 18, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50309774 ↗
  • InjuryAug 18, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50309762 ↗
  • InjuryJul 30, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50092643 ↗
  • InjuryJul 30, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50092640 ↗
  • InjuryJun 10, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: Unspecified Infection

    MAUDE report 25464283 ↗
  • InjuryJun 10, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: Unspecified Infection

    MAUDE report 25464276 ↗
  • InjuryJan 15, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: Implant Pain

    MAUDE report 24088599 ↗
  • InjuryJan 15, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: Implant Pain

    MAUDE report 24088571 ↗
  • InjuryJan 15, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE

    Patient problems: Implant Pain

    MAUDE report 24088548 ↗
  • InjuryJan 15, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: Implant Pain

    MAUDE report 24088547 ↗
  • InjuryApr 17, 2024Loss of Osseointegration; Loss of Osseointegration

    IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 19128488 ↗
  • InjuryApr 17, 2024Loss of Osseointegration; Loss of Osseointegration

    IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 19128475 ↗
  • InjuryApr 17, 2024Loss of Osseointegration; Loss of Osseointegration

    IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 19128470 ↗
  • InjuryApr 17, 2024Loss of Osseointegration; Loss of Osseointegration

    IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant

    MAUDE report 19128460 ↗
  • InjuryMar 24, 2023Loss of Osseointegration; Loss of Osseointegration

    IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant; Pain

    MAUDE report 16614712 ↗
  • InjuryMar 24, 2023Loss of Osseointegration; Loss of Osseointegration

    IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.

    Patient problems: Failure of Implant; Pain

    MAUDE report 16614659 ↗
  • InjuryMar 24, 2023Failure to Osseointegrate; Failure to Osseointegrate

    IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.

    Patient problems: Failure of Implant; Pain

    MAUDE report 16614404 ↗
  • InjuryMar 24, 2023Failure to Osseointegrate; Failure to Osseointegrate

    IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.

    Patient problems: Failure of Implant; Pain

    MAUDE report 16614403 ↗
  • InjuryFeb 10, 2023Failure to Osseointegrate; Failure to Osseointegrate

    IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.

    Patient problems: Failure of Implant; Pain

    MAUDE report 16357333 ↗
  • InjuryFeb 10, 2023Failure to Osseointegrate; Failure to Osseointegrate

    IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE.

    Patient problems: Failure of Implant; Pain

    MAUDE report 16357276 ↗

Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices

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Sources and updates

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