Nobel Biocare N1™ 300860Recalls & reported problems
Nobel Biocare AB · Nobel Biocare N1™ TiUltra™ TCC RP 4.0x7mm · Class 2 · Implant
All models of Nobel Biocare N1 (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Nobel Biocare N1 dental implant is placed in the jawbone to hold a tooth replacement. Its 551 reports mostly describe the implant failing to bond with the jawbone or losing that bond, and some describe infection and pain. The reports include 545 injuries and no deaths. 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
- 558
- Deaths reported
- 0
- Injuries reported
- 552
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 558 adverse event reports that list this exact device (DI 07332747161724), received between Feb 8, 2022 and Sep 16, 2026 — classified as 552 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (357 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate357
- Loss of Osseointegration109
- Osseointegration Problem42
- Adverse Event Without Identified Device or Use Problem8
- Migration8
- Patient Device Interaction Problem8
- Premature Separation8
- Material Deformation6
Patient problems
- Failure of Implant390
- No Clinical Signs, Symptoms or Conditions131
- Unspecified Infection36
- Pain30
- Inflammation8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available7
- Implant Pain6
- Abscess4
Recent adverse event reports
The 25 most recent of 558 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795920 ↗InjurySep 16, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795911 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764894 ↗InjurySep 14, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764892 ↗InjurySep 8, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50677684 ↗InjurySep 8, 2026Osseointegration Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50677667 ↗InjuryAug 20, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50358614 ↗InjuryAug 16, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50266307 ↗InjuryAug 16, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50264867 ↗InjuryAug 11, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50214938 ↗InjuryAug 11, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50214932 ↗InjuryAug 7, 2026Failure to Osseointegrate
InjuryAug 7, 2026Failure to Osseointegrate
InjuryAug 6, 2026Failure to Osseointegrate
Failure to osseointegrate
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50167875 ↗InjuryAug 6, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50167870 ↗InjuryAug 4, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50135255 ↗InjuryAug 4, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50135252 ↗InjuryJul 29, 2026Osseointegration Problem
Lack of stability during placement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50076563 ↗InjuryJul 6, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25726444 ↗InjuryJul 6, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25726441 ↗InjuryJul 4, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25711645 ↗InjuryJul 4, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25711643 ↗InjuryJul 4, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25711632 ↗InjuryJul 4, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25711631 ↗InjuryJul 4, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25711627 ↗
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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