Nobel Biocare N1™ 300859Recalls & reported problems
Nobel Biocare AB · Nobel Biocare N1™ TiUltra™ TCC NP 3.5x13mm · Class 2 · Implant
All models of Nobel Biocare N1 (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Nobel Biocare N1 dental implant is placed into the jawbone. Its 460 reports mostly describe the implant failing to bond with the bone, with some reports of infection, pain and abscesses. The reports include no deaths and 458 injuries. There is 1 open recall, started in July 2022, because a rough burr on the implant could be breathed into the airway during surgery.
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
- 464
- Deaths reported
- 0
- Injuries reported
- 462
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 464 adverse event reports that list this exact device (DI 07332747161717), received between Feb 2, 2022 and Sep 30, 2026 — classified as 462 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Osseointegrate” (338 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Jul 25, 2022Class IIOpen, Classified
Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.
Z-1565-2022 · Root cause: Process change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Osseointegrate338
- Loss of Osseointegration64
- Osseointegration Problem40
- Adverse Event Without Identified Device or Use Problem8
- Migration6
- Activation, Positioning or Separation Problem2
- Fracture2
- Patient Device Interaction Problem2
Patient problems
- Failure of Implant296
- No Clinical Signs, Symptoms or Conditions114
- Unspecified Infection30
- Pain28
- Abscess14
- Implant Pain14
- Inflammation12
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
Recent adverse event reports
The 25 most recent of 464 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Inflammation
MAUDE report 50953410 ↗InjurySep 30, 2026Failure to Osseointegrate
Patient problems: Inflammation
MAUDE report 50953408 ↗InjurySep 9, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700344 ↗InjurySep 9, 2026Failure to Osseointegrate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700331 ↗InjuryAug 17, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50287961 ↗InjuryAug 17, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50287954 ↗InjuryAug 8, 2026Loss of Osseointegration
InjuryAug 8, 2026Loss of Osseointegration
InjuryAug 7, 2026Failure to Osseointegrate
InjuryAug 7, 2026Failure to Osseointegrate
InjuryAug 7, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50183256 ↗InjuryAug 7, 2026Failure to Osseointegrate
Failure to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50183255 ↗InjuryJul 30, 2026Failure to Osseointegrate
InjuryJul 30, 2026Failure to Osseointegrate
InjuryJul 28, 2026Failure to Osseointegrate
InjuryJul 28, 2026Failure to Osseointegrate
InjuryJul 17, 2026Failure to Osseointegrate
InjuryJul 17, 2026Failure to Osseointegrate
InjuryJul 15, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25832443 ↗InjuryJul 15, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25832281 ↗InjuryJul 13, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25805481 ↗InjuryJul 13, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25805476 ↗InjuryJul 8, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25754481 ↗InjuryJul 8, 2026Osseointegration Problem
LACK OF STABILITY DURING PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25754473 ↗InjuryJul 7, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25740176 ↗
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
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- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- 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 · each recall links to the FDA recall notice
- 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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