Nobel Biocare N1™ 300858Recalls & reported problems
Nobel Biocare AB · Nobel Biocare N1™ TiUltra™ TCC NP 3.5x11mm · 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 has 693 adverse event reports, with no deaths and 685 injuries. Most describe the implant failing to bond with the surrounding bone, and patients reported implant failure, infection, pain and inflammation. 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
- 708
- Deaths reported
- 0
- Injuries reported
- 700
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 708 adverse event reports that list this exact device (DI 07332747161700), received between Jan 28, 2022 and Sep 29, 2026 — classified as 700 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (505 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 Osseointegrate505
- Loss of Osseointegration97
- Osseointegration Problem64
- Adverse Event Without Identified Device or Use Problem16
- Migration8
- Fracture6
- Patient Device Interaction Problem6
- Insufficient Device Problem Information4
Patient problems
- Failure of Implant475
- No Clinical Signs, Symptoms or Conditions168
- Unspecified Infection56
- Pain42
- Implant Pain14
- Inflammation10
- Abscess8
- Numbness6
Recent adverse event reports
The 25 most recent of 708 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940481 ↗InjurySep 29, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940478 ↗InjurySep 16, 2026Osseointegration Problem
Patient problems: Inflammation
MAUDE report 50795858 ↗InjurySep 16, 2026Osseointegration Problem
Patient problems: Inflammation
MAUDE report 50795852 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795478 ↗InjurySep 16, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795470 ↗InjurySep 9, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700408 ↗InjurySep 9, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700405 ↗InjurySep 8, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678270 ↗InjurySep 8, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678267 ↗InjurySep 8, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678182 ↗InjurySep 8, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678168 ↗InjurySep 8, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678146 ↗InjurySep 8, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50678144 ↗InjuryAug 21, 2026Loss of Osseointegration
InjuryAug 18, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50310080 ↗InjuryAug 18, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50310062 ↗InjuryAug 8, 2026Loss of Osseointegration
InjuryAug 8, 2026Loss of Osseointegration
InjuryAug 7, 2026Failure to Osseointegrate
InjuryAug 7, 2026Failure to Osseointegrate
InjuryAug 4, 2026Failure to Osseointegrate
InjuryAug 4, 2026Failure to Osseointegrate
InjuryJul 28, 2026Failure to Osseointegrate
InjuryJul 28, 2026Failure to Osseointegrate
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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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