Nobel Biocare N1™ 301170Recalls & reported problems
Nobel Biocare AB · Nobel Biocare N1™ TiUltra™ TCC RP 4.0x15mm · 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 root-form implant is placed in bone. Of its 173 reports, 169 are filed as injuries, and most describe the implant failing to fuse with the bone, with some reporting infection, pain, or a fistula. The reports mention no deaths, and no recalls name this device. Reports rose over the past 12 months, with 58 compared with 35 in the year before.
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
- 183
- Deaths reported
- 0
- Injuries reported
- 179
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 183 adverse event reports that list this exact device (DI 07332747171143), received between Aug 19, 2022 and Sep 30, 2026 — classified as 179 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (133 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 Osseointegrate133
- Loss of Osseointegration24
- Osseointegration Problem8
- Patient Device Interaction Problem6
- Adverse Event Without Identified Device or Use Problem4
- Device Markings/Labelling Problem2
- Difficult to Insert2
- Material Deformation2
Patient problems
- No Clinical Signs, Symptoms or Conditions90
- Failure of Implant84
- Unspecified Infection10
- Pain8
- Fistula4
- Abscess2
- Implant Pain2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 183 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 50954284 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954273 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954047 ↗InjurySep 30, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954040 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795606 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795604 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50723760 ↗InjurySep 10, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50723758 ↗InjurySep 8, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678371 ↗InjurySep 8, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678360 ↗InjuryAug 27, 2026Failure to Osseointegrate
InjuryAug 27, 2026Failure to Osseointegrate
InjuryAug 25, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50440837 ↗InjuryAug 25, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50440836 ↗InjuryJul 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25863465 ↗InjuryJul 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25863455 ↗InjuryJul 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25863447 ↗InjuryJul 17, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25863431 ↗InjuryJul 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25740332 ↗InjuryJul 7, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25740330 ↗InjuryJun 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25629212 ↗InjuryJun 25, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25629206 ↗InjuryJun 24, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25614889 ↗InjuryJun 24, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25614874 ↗InjuryJun 24, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25614865 ↗
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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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