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NobelReplace® 37287 (UDI 07332747160673)Recalls & reported problems

Nobel Biocare AB · NobelReplace® Conical Connection PMC NP 3.5x11.5mm · Class 2 · Implant

Quick summary

This NobelReplace dental implant is a root-form implant placed in the jawbone. Its 3,294 reports mostly describe the implant failing to fuse with the jawbone, with some implants moving out of position or lacking stability during placement. The reports include no deaths and 3,262 injuries. No recalls name this device. Reports fell in the most recent year (647) from the year before (1,077).

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
3,329
Deaths reported
0
Injuries reported
3,297
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3,329 adverse event reports that list this exact device (DI 07332747160673), received between Oct 29, 2021 and Sep 30, 2026 — classified as 3,297 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (2,679 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: 38 reportsJan 2024: 54 reportsFeb 2024: 36 reportsMar 2024: 51 reportsApr 2024: 76 reportsMay 2024: 48 reportsJun 2024: 58 reportsJul 2024: 38 reportsAug 2024: 39 reportsSep 2024: 57 reportsOct 2024: 53 reportsNov 2024: 93 reportsDec 2024: 92 reportsJan 2025: 118 reportsFeb 2025: 78 reportsMar 2025: 108 reportsApr 2025: 26 reportsMay 2025: 0 reportsJun 2025: 9 reportsJul 2025: 315 reportsAug 2025: 136 reportsSep 2025: 48 reportsOct 2025: 54 reportsNov 2025: 100 reportsDec 2025: 78 reportsJan 2026: 90 reportsFeb 2026: 36 reportsMar 2026: 52 reportsApr 2026: 60 reportsMay 2026: 64 reportsJun 2026: 61 reportsJul 2026: 54 reportsAug 2026: 55 reportsSep 2026: 32 reportsOct 2026: 0 reports202420252026315
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Osseointegrate2,679
  • Loss of Osseointegration405
  • Osseointegration Problem124
  • Fracture46
  • Adverse Event Without Identified Device or Use Problem35
  • Migration10
  • Patient Device Interaction Problem9
  • Insufficient Device Problem Information4

Patient problems

  • Failure of Implant2,064
  • No Clinical Signs, Symptoms or Conditions907
  • Unspecified Infection405
  • Pain228
  • Numbness67
  • Abscess42
  • Inflammation40
  • Implant Pain36

Recent adverse event reports

The 25 most recent of 3,329 reports, in the reporter's own words as published by the FDA.

  • InjurySep 30, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50954169 ↗
  • InjurySep 30, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50954166 ↗
  • InjurySep 29, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50940030 ↗
  • InjurySep 29, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50940018 ↗
  • InjurySep 28, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50924947 ↗
  • InjurySep 28, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50924946 ↗
  • InjurySep 28, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50924813 ↗
  • InjurySep 28, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50924808 ↗
  • InjurySep 17, 2026Loss of Osseointegration

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

    MAUDE report 50812058 ↗
  • InjurySep 17, 2026Loss of Osseointegration

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

    MAUDE report 50812056 ↗
  • InjurySep 17, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50810842 ↗
  • InjurySep 17, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50810836 ↗
  • InjurySep 17, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50810835 ↗
  • InjurySep 17, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50810830 ↗
  • InjurySep 16, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50795764 ↗
  • InjurySep 16, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50795759 ↗
  • InjurySep 16, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50795727 ↗
  • InjurySep 16, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50795726 ↗
  • InjurySep 16, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50795711 ↗
  • InjurySep 16, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50795710 ↗
  • InjurySep 14, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50764829 ↗
  • InjurySep 14, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50764826 ↗
  • InjurySep 14, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: Hypersensitivity/Allergic reaction

    MAUDE report 50748832 ↗
  • InjurySep 14, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: Hypersensitivity/Allergic reaction

    MAUDE report 50748831 ↗
  • InjurySep 11, 2026Failure to Osseointegrate

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50742678 ↗

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.