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NobelReplace® 32182Recalls & reported problems

Nobel Biocare AB · NOBELREPLACE Straight Groovy RP 4x11.5mm · Class 2 · Implant

Quick summary

This NobelReplace dental implant from Nobel Biocare appears in 268 adverse event reports, with no deaths and 267 injuries. The reports mostly describe the implant failing to bond with the jawbone, with some also mentioning infection, pain and fractures. Reports fell to 28 in the last 12 months from 48 in the year before. 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
282
Deaths reported
0
Injuries reported
281
Recalls naming it
0

Summary

The FDA's MAUDE database contains 282 adverse event reports that list this exact device (DI 07332747019049), received between Sep 11, 2019 and Sep 29, 2026 — classified as 281 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (224 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: 2 reportsDec 2023: 4 reportsJan 2024: 10 reportsFeb 2024: 0 reportsMar 2024: 6 reportsApr 2024: 16 reportsMay 2024: 6 reportsJun 2024: 4 reportsJul 2024: 0 reportsAug 2024: 2 reportsSep 2024: 4 reportsOct 2024: 2 reportsNov 2024: 2 reportsDec 2024: 4 reportsJan 2025: 0 reportsFeb 2025: 4 reportsMar 2025: 6 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 2 reportsJul 2025: 10 reportsAug 2025: 16 reportsSep 2025: 4 reportsOct 2025: 0 reportsNov 2025: 8 reportsDec 2025: 2 reportsJan 2026: 0 reportsFeb 2026: 2 reportsMar 2026: 6 reportsApr 2026: 4 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 4 reportsAug 2026: 10 reportsSep 2026: 6 reportsOct 2026: 0 reports20242025202616
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Loss of Osseointegration224
  • Fracture28
  • Failure to Osseointegrate10
  • Osseointegration Problem8
  • Adverse Event Without Identified Device or Use Problem4
  • Difficult to Insert2
  • Insufficient Device Problem Information2
  • Mechanical Problem2

Patient problems

  • Failure of Implant204
  • Unspecified Infection78
  • No Clinical Signs, Symptoms or Conditions28
  • Pain22
  • Foreign Body In Patient2
  • Insufficient Information2

Recent adverse event reports

The 25 most recent of 282 reports, in the reporter's own words as published by the FDA.

  • InjurySep 29, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50940146 ↗
  • InjurySep 29, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50940138 ↗
  • InjurySep 19, 2026Loss of Osseointegration

    Patient problems: Unspecified Infection

    MAUDE report 50833301 ↗
  • InjurySep 19, 2026Loss of Osseointegration

    Patient problems: Unspecified Infection

    MAUDE report 50833297 ↗
  • InjurySep 16, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50796190 ↗
  • InjurySep 16, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50796188 ↗
  • InjuryAug 19, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: Unspecified Infection

    MAUDE report 50332787 ↗
  • InjuryAug 19, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: Unspecified Infection

    MAUDE report 50332772 ↗
  • InjuryAug 19, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: Unspecified Infection

    MAUDE report 50332765 ↗
  • InjuryAug 19, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: Unspecified Infection

    MAUDE report 50332757 ↗
  • InjuryAug 19, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: Unspecified Infection

    MAUDE report 50332657 ↗
  • InjuryAug 19, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: Unspecified Infection

    MAUDE report 50332655 ↗
  • InjuryAug 19, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: Unspecified Infection

    MAUDE report 50332652 ↗
  • InjuryAug 19, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: Unspecified Infection

    MAUDE report 50332649 ↗
  • InjuryAug 12, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50228541 ↗
  • InjuryAug 12, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50228539 ↗
  • InjuryJul 27, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50027340 ↗
  • InjuryJul 27, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50027339 ↗
  • InjuryJul 27, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50002841 ↗
  • InjuryJul 27, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50002840 ↗
  • InjuryApr 18, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24920529 ↗
  • InjuryApr 18, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24920462 ↗
  • InjuryApr 18, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24920460 ↗
  • InjuryApr 18, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24920348 ↗
  • InjuryMar 17, 2026Loss of Osseointegration

    LOSS OF OSSEOINTEGRATION.

    Patient problems: Unspecified Infection

    MAUDE report 24622860 ↗

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.