Nobel Biocare N1™ 300857Recalls & reported problems
Nobel Biocare AB · Nobel Biocare N1™ TiUltra™ TCC NP 3.5x9mm · 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 implant appears in 643 adverse event reports, 637 of which describe injuries, with no deaths. Most reports describe the implant not fusing with the bone, and some mention pain, infection, or implants that shifted or came loose. 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
- 641
- Deaths reported
- 0
- Injuries reported
- 635
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 641 adverse event reports that list this exact device (DI 07332747161694), received between Feb 8, 2022 and Sep 11, 2026 — classified as 635 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (433 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 Osseointegrate433
- Loss of Osseointegration114
- Osseointegration Problem52
- Adverse Event Without Identified Device or Use Problem22
- Migration6
- Fracture4
- Patient Device Interaction Problem4
- Premature Separation4
Patient problems
- Failure of Implant410
- No Clinical Signs, Symptoms or Conditions164
- Unspecified Infection53
- Pain44
- Implant Pain32
- Inflammation12
- Abscess8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
Recent adverse event reports
The 25 most recent of 641 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50742758 ↗InjurySep 11, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50742756 ↗InjuryAug 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486657 ↗InjuryAug 27, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50486656 ↗InjuryAug 11, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215301 ↗InjuryAug 11, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50215298 ↗InjuryAug 8, 2026Loss of Osseointegration
InjuryAug 8, 2026Loss of Osseointegration
InjuryAug 8, 2026Failure to Osseointegrate
InjuryAug 8, 2026Failure to Osseointegrate
InjuryAug 7, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50182466 ↗InjuryAug 7, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50182460 ↗InjuryAug 4, 2026Loss of Osseointegration
InjuryAug 4, 2026Loss of Osseointegration
InjuryJul 29, 2026Failure to Osseointegrate
InjuryJul 27, 2026Loss of Osseointegration
InjuryJul 27, 2026Loss of Osseointegration
InjuryJul 15, 2026Failure to Osseointegrate
InjuryJul 15, 2026Failure to Osseointegrate
InjuryJul 15, 2026Failure to Osseointegrate
InjuryJul 15, 2026Failure to Osseointegrate
InjuryJul 13, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25807089 ↗InjuryJul 13, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25807079 ↗InjuryJul 13, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25806898 ↗InjuryJul 13, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25806894 ↗
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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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