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NobelSpeedy® 37611 (UDI 07332747161021)Recalls & reported problems

Nobel Biocare AB · NobelSpeedy® Groovy RP 4.0x20mm · Class 2 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Quick summary

This NobelSpeedy dental implant from Nobel Biocare has 223 adverse event reports, including 221 injuries and 2 malfunctions, and no deaths. Most reports describe the implant failing to fuse with the jawbone or losing its hold in the bone, and some describe a lack of stability during placement. 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
231
Deaths reported
0
Injuries reported
229
Recalls naming it
0

Summary

The FDA's MAUDE database contains 231 adverse event reports that list this exact device (DI 07332747161021), received between Nov 18, 2021 and Sep 17, 2026 — classified as 229 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Osseointegrate” (167 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: 4 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 2 reportsApr 2024: 2 reportsMay 2024: 2 reportsJun 2024: 6 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 2 reportsOct 2024: 2 reportsNov 2024: 6 reportsDec 2024: 2 reportsJan 2025: 2 reportsFeb 2025: 2 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 14 reportsAug 2025: 10 reportsSep 2025: 6 reportsOct 2025: 6 reportsNov 2025: 8 reportsDec 2025: 10 reportsJan 2026: 8 reportsFeb 2026: 6 reportsMar 2026: 6 reportsApr 2026: 8 reportsMay 2026: 4 reportsJun 2026: 4 reportsJul 2026: 11 reportsAug 2026: 2 reportsSep 2026: 8 reportsOct 2026: 0 reports20242025202614
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Failure to Osseointegrate167
  • Loss of Osseointegration44
  • Osseointegration Problem8
  • Patient Device Interaction Problem6
  • Adverse Event Without Identified Device or Use Problem4
  • Mechanical Problem2

Patient problems

  • Failure of Implant114
  • No Clinical Signs, Symptoms or Conditions85
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available22
  • Unspecified Infection12
  • Pain10
  • Numbness6
  • Inflammation4
  • Implant Pain2

Recent adverse event reports

The 25 most recent of 231 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 50811951 ↗
  • InjurySep 17, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50811949 ↗
  • InjurySep 17, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50811933 ↗
  • InjurySep 17, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50811931 ↗
  • InjurySep 17, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50811897 ↗
  • InjurySep 17, 2026Loss of Osseointegration

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50811896 ↗
  • InjurySep 14, 2026Osseointegration Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50764436 ↗
  • InjurySep 14, 2026Osseointegration Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50764432 ↗
  • InjuryAug 12, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50228971 ↗
  • InjuryAug 12, 2026Loss of Osseointegration

    Loss of osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50228966 ↗
  • InjuryJul 29, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50076847 ↗
  • InjuryJul 27, 2026Failure to Osseointegrate

    Failure to osseointegration.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50026392 ↗
  • InjuryJul 27, 2026Failure to Osseointegrate

    Failure to osseointegrate.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50026388 ↗
  • InjuryJul 13, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25807365 ↗
  • InjuryJul 13, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25807364 ↗
  • InjuryJul 13, 2026Osseointegration Problem

    LACK OF STABILITY DURING PLACEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25804847 ↗
  • InjuryJul 13, 2026Osseointegration Problem

    LACK OF STABILITY DURING PLACEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25804846 ↗
  • InjuryJul 3, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25708911 ↗
  • InjuryJul 3, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25708907 ↗
  • InjuryJul 3, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25708884 ↗
  • InjuryJul 3, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25708857 ↗
  • InjuryJun 11, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

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

    MAUDE report 25479783 ↗
  • InjuryJun 11, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

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

    MAUDE report 25479752 ↗
  • InjuryJun 5, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

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

    MAUDE report 25417366 ↗
  • InjuryJun 5, 2026Failure to Osseointegrate

    FAILURE TO OSSEOINTEGRATE.

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

    MAUDE report 25417114 ↗

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Sources and updates

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